A Randomized, Double-blind, Comparator-controlled, Cross-over Study to Investigate the Safety and Efficacy of RiaGev™ in Healthy Adults
Phase: NA
Conditions: Metabolic Syndrome, Premature Aging
Sponsor: Bioenergy Life Science, Inc.

Page 1 of 52 
 
CLINICAL PROTOCOL COVER PAGE 
 
 
Protocol Title: 
 A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults  
 
Protocol Number: 
 
19RNHB 
 
Protocol Date:  
 
 October 7th, 2019 
 
Version: 
2 
 
Study Design: 
 
randomized, double-blind, comparator-controlled, cross-over study 
 
Sponsor: 
 
 
Bioenergy Life Science, Inc. 
 
 
 
 
13840 Johnson St NE 
 
 
 
 
Ham Lake, MN 55304, USA 
 
 
Sponsor Contact: 
 
Alex Xue 
 
 
 
 
763-746-3924 
 
 
 
 
alex.xue@bioenergyls.com 
  
 
 
 
 
 
CRO:  
 
 
KGK Science Inc. 
 
 
 
 
 
 
 
 
 
 
Suite 1440, One London Place  
 
 
 
 
 
 
 
 
255 Queens Ave 
 
 
 
 
 
 
 
 
 
 
London Ontario N6A 5R8 
 
 
 
 
 
 
 
 
 
Canada  
 
 
 
 
 
 
 
 
 
 
 
519-438-9374 
 
Principal Investigator: 
Trisha Shamp, PA-C, MPAS, PhD 
1000 Westgate Drive Suite 149 
Saint Paul, MN 55114 
USA   
651-641-2900  
 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 2 of 52 
 
PROTOCOL SIGNATURE SHEET 
The sponsor and the investigator agree to conduct the study in compliance with the clinical study protocol 
(and amendments), International Conference on Harmonization (ICH) guidelines for current Good 
Clinical Practice (cGCP) and applicable regulatory requirements. 
Name 
Signature 
Date 
Sponsor:  
Alex Xue 
763-746-3924 
alex.xue@bioenergyls.com 
13840 Johnson St NE 
Andover, MN 55304, USA 
 
 
Contract Research Organization:  
Malkanthi Evans, PhD 
Chief Scientific Officer  
KGK Science Inc. 
255 Queens Ave., 
Suite 1440 
London, ON N6A 5R8 
Canada  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 3 of 52 
 
1 
PROTOCOL SYNOPSIS  
Population: Healthy male and females  
 
Total number of participants: 18 
 
Inclusion Criteria 
 
1. Healthy male and females between the ages of 35 and 65 years of age, inclusive 
2. BMI between 18.5 to 29.9 kg/m2, inclusive  
3. Female participant is not of child-bearing potential, defined as females who have undergone a 
sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, 
complete endometrial ablation) or have been post-menopausal (natural or surgically) for at least 
1 year prior to screening 
 
Or,  
Females of child-bearing potential must have a negative urine pregnancy test at screening and 
baseline and agree to use a medically approved method of birth control for the duration of the 
study. All hormonal birth control must have been in use for a minimum of three months. 
Acceptable methods of birth control include: 
• 
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho 
Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, 
Lunelle), or hormone implant (Norplant System) 
• 
Double-barrier method  
• 
Intrauterine devices 
• 
Non-heterosexual lifestyle or agrees to use contraception if planning on changing to 
heterosexual partner(s) 
• 
Vasectomy of partner at least 6 months prior to screening  
4. Healthy as determined by laboratory results, medical history, physical exam, and EKG 
5. Agrees to avoid supplementation with tryptophan and vitamin B3 or its derivatives (niacin, 
nicotinic acid, niacinamide) one week prior to randomization and during the study 
6. Ability to complete maximal and submaximal exercise tests  
7. Agrees to maintain current diet and activity level throughout the study  
8. Agrees to comply to all study procedures  
9. Has given voluntary, written, informed consent to participate in the study 
10. Self-reported good sleeper at screening. Have a regular sleep cycle with a bedtime between 
the approximate hours of 9:00pm and 12:00am and regularly receive between 7-9 hours of 
sleep, and agrees to maintain this sleep schedule throughout the study  
 
 
Exclusion Criteria 
 
1. Women who are pregnant, breast feeding, or planning to become pregnant during the trial 
2. Allergy or sensitivity to investigational product’s ingredients or standard meal provided 
3. Current or ex-smokers within the past year 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
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Page 4 of 52 
 
4. Major surgery within the past 3 months which may impact the study outcomes to be assessed 
by the QI. 
5. Untreated/unresolved/uncontrolled cardiovascular disease. Participants with no significant 
cardiovascular event in the past 1 year and on stable medication may be included after 
assessment by the QI on a case by case basis  
6. Self reported current or pre-existing thyroid condition. Treatment on a stable dose medication 
for over 3 months will be reviewed on a case-by-case basis by the QI 
7. Current or history of hypertension.  
8. Type I or Type II diabetes 
9. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a 
follow up that is negative. Volunteers with cancer in full remission for more than five years 
after diagnosis are acceptable 
10. Self reported of any autoimmune disease or immune-compromised  
11. Self reported by subjects of being HIV or Hepatitis B/C positive 
12. History or currently with kidney and liver diseases assessed by QI on a case by case basis, 
with the exception of history of kidney stones symptom free for 1 year 
13. Known medical or psychological condition that, in the qualified investigator’s opinion, could 
interfere with study participation 
14. Significant gastrointestinal disease (examples include but are not limited to Celiac disease and 
inflammatory bowel disease) 
15. Self reported of bleeding disorders. 
16. Current diagnosis of gout within past three months as per the QI’s assessment 
17. Clinically significant abnormal laboratory results at screening as assessed by QI 
18. Current use of prescribed medications or over the counter supplements that may interfere with 
the IP assessed by QI (See Section 7.3) 
19. Alcohol consumption of >2 standard drinks/day or >14 drinks/week 
20. Alcohol or drug abuse within the past 12 months 
21. Use of medical marijuana 
22. Frequent use of recreational drugs within 6 months of baseline assessed as per QI 
23. Planned blood donation during or within 30 days following conclusion of clinical trial 
24. Participation in other clinical research trials 30 days prior to baseline  
25. Participants that are cognitively impaired and/or who are unable to give informed consent 
26. Any other active or unstable medical condition, that, in the opinion of the QI, may adversely 
affect the participant's ability to complete the study or its measures or pose significant risk to 
the participant. 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 5 of 52 
 
 
Schedule of Assessments 
 
Period 1 
 
 
 
Period 2 
 
Procedures/assessments 
Visit 
1 
Scree
n  
Visit 2 
Day 1 
(+1 
Day) 
Visit 3 
Day 3 
(+1 
Day) 
Visit 4 
Day 5 
(+1 
Day) 
Visit 5 
Day 8 
(+1 Day) 
 
 
Visit 6 
Day 1 
(+1 
Day) 
Visit 7 
Day 3 
(+1 
Day) 
Visit 8 
Day 5 
(+1 
Day) 
Visit 9 
Day 8 
(+1 
Day) 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
Review inclusion/exclusion 
criteria 
X 
X 
 
 
 
 
 
 
 
 
Review medical history 
X 
 
 
 
 
 
 
 
 
 
Review concomitant 
therapies 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
Vitals: Height*, weight, heart 
rate, blood pressure 
*Height will only be 
measured at Visit 1 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
Urine pregnancy test 
X 
X 
 
 
 
 
 
 
 
 
Electrocardiogram (EKG) 
X 
 
 
 
 
 
 
 
 
 
Physical examination 
X 
X 
 
 
 
 
 
 
 
X 
Randomization 
 
X 
 
 
 
 
 
 
 
 
CBC, electrolytes (Na, K, Cl), 
HbA1c*, fasting glucose, 
eGFR, creatinine, AST, ALT, 
and total bilirubin 
*HbA1c will only be 
measured at Visit 1 
X 
 
 
 
X 
 
X 
 
 
X 
Maximum heart rate (HRmax) 
treadmill test  
X 
 
 
 
 
 
 
 
 
 
Skin fluoroscopy for NADH 
analysis (optional) 
 
X 
 
 
X 
 
X 
 
 
X 
Blood Collection for NAD+ 
analysis 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
Blood Collection for 
GSH/GSSG and ATP/AMP 
analyses  
 
X 
 
 
X 
 
X 
 
 
X 
OGTT: glucose and insulin T= 
0, 15m, 30m, 45m, 60m, 
90m, 2h 
 
X 
 
 
X 
 
X 
 
 
X 
Questionnaire 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
Treadmill Exercise protocol  
 
X 
 
 
X 
 
X 
 
 
X 
Salivary Collection Kit 
Dispensed 
X 
X 
X 
X 
X 
 
X 
X 
X 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
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Page 6 of 52 
 
 
Procedures/assessments 
Visit 
1 
Scree
n 
 
Visit 2 
Day 1 
(+1 
Day) 
Visit 3 
Day 3 
(+1 
Day) 
Visit 4 
Day 5 
(+1 
Day) 
Visit 5 
Day 8 
(+1 Day) 
 
 
Visit 6 
Day 1 
(+1 
Day) 
Visit 7 
Day 3 
(+1 
Day) 
Visit 8 
Day 5 
(+1 
Day) 
Visit 9 
Day 8 
(+1 
Day) 
Salivary Collection Kit 
Returned  
 
X 
X 
X 
X 
 
X 
X 
X 
X 
Food Records Dispensed 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
Food Records Collected 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
IP Dispensed 
 
X 
X 
X 
 
 
X 
X 
X 
 
IP Returned  
 
 
X 
X 
X 
 
 
X 
X 
X 
Subject Diary Dispensed 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
Subject Diary Returned 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
Standardized Meal 
 
X 
 
 
X 
 
X 
 
 
X 
Compliance Calculated 
 
 
X 
X 
X 
 
 
X 
X 
X 
Adverse Events  
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
 
 
7-day washout  
(+3 days) 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
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Page 7 of 52 
 
2 
LIST OF ABBREVIATIONS  
AE 
Adverse Event 
ALT 
Alanine Aminotransferase 
AST 
Aspartate Aminotransferase 
ATP 
Adenosine triphosphate 
BMI 
Body Mass Index 
BP 
Blood Pressure 
CBC 
Complete Blood Count 
CRF 
Case Report Form 
Cl 
Chloride 
DNA 
Deoxyribonucleic acid 
DOB 
Date of Birth 
EDTA 
Ethylenediaminetetraacetic Acid 
eGFR 
Glomerular Filtration Rate  
etc. 
“and so forth” 
e.g. 
“for example” 
et al 
“and others” 
FDA 
US Food and Drug Administration 
g 
Gram 
GCP 
Good Clinical Practice 
G-6-PDH 
glucose-6-phosphate dehydrogenase 
GSH 
Glutathione  
GSSG 
Glutathione disulfide  
GRAS 
Generally Recognized as Safe 
HDL 
High-density lipoprotein 
HR 
Heart rate 
lbs. 
Pounds 
ICF 
Informed Consent Form 
ICH 
International Conference of Harmonization 
IP 
Investigational Product 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
K 
Potassium 
kg 
Kilogram 
LDL 
Low-density lipoprotein 
MCH 
Mean Corpuscular Hemoglobin 
MCHC 
Mean Corpuscular Hemoglobin Concentration 
MCV 
Mean Corpuscular Volume 
Na 
Sodium 
NAD+ 
nicotinamide adenine dinucleotide 
NADP 
Nicotinamide adenine dinucleotide phosphate 
NR 
nicotinamide riboside 
OGTT 
oral glucose tolerance test 
OTC 
Off-the-counters  
PP 
Per Protocol 
PPP 
pentose phosphate pathway 
PRB 
Population Reference Bureau 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 8 of 52 
 
QI 
Qualified Investigator 
RBC 
Red Blood Cells 
RDW 
Red Blood Cell Distribution Width  
RNA 
Ribonucleic acid 
SAE 
Serious Adverse Event 
SOP 
Standard operating procedure 
SST 
Serum Separating Tube 
UAT 
User Acceptance Testing 
WBC 
White Blood Cell 
WHO 
World Health Organization 
 
 
 
 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 9 of 52 
 
3 
TABLE OF CONTENTS 
 
1 
PROTOCOL SYNOPSIS ............................................................................................................... 3 
2 
LIST OF ABBREVIATIONS ......................................................................................................... 7 
3 
TABLE OF CONTENTS ................................................................................................................ 9 
4 
INTRODUCTION ......................................................................................................................... 12 
5 
STUDY OBJECTIVES ................................................................................................................. 14 
6 
STUDY DESIGN ........................................................................................................................... 15 
7 
SELECTION OF STUDY POPULATION ................................................................................. 16 
7.3.1 
Prescribed Medications ..................................................................................................... 17 
7.3.2 
Over-the-counter Medications, Supplements ...................................................................... 18 
8 
INVESTIGATIONAL PRODUCT .............................................................................................. 20 
9 
STUDY ASSESSMENTS .............................................................................................................. 22 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 10 of 52 
 
9.12.1 
Height and Weight .............................................................................................................. 30 
9.12.2 
Blood Pressure and Heart Rate ............................................................................................ 30 
9.12.3 
Blood Sample Collection .................................................................................................... 31 
9.12.4 
Checklist Individual Strength Questionnaire (CIS) Questionnaire ..................................... 31 
9.12.5 
Saliva Sample Collection .................................................................................................... 32 
9.12.6 
Maximum Heart Rate Treadmill Test ................................................................................. 32 
9.12.7 
Treadmill Exercise .............................................................................................................. 32 
9.12.8 
Skin Fluorescence (Optional) .............................................................................................. 32 
9.12.9 
Food Records ....................................................................................................................... 32 
10 
SAFETY INSTRUCTIONS AND GUIDANCE ..................................................................... 37 
10.1.1 
Adverse Events .................................................................................................................... 37 
10.1.2 
Serious Adverse Event ........................................................................................................ 38 
10.1.3 
Unexpected Adverse Reaction ............................................................................................ 38 
10.1.4 
Laboratory Test Abnormalities ........................................................................................... 38 
10.2.1 
Treatment and Follow-up of AEs ........................................................................................ 39 
10.2.2 
Treatment and Follow-up of Laboratory Abnormalities ..................................................... 39 
11 
STATISTICAL EVALUATION .............................................................................................. 40 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 11 of 52 
 
11.3.1 
Premature Discontinuation Description .............................................................................. 41 
11.3.2 
Safety ................................................................................................................................... 41 
12 
DATA COLLECTION AND STORAGE ............................................................................... 41 
13 
ETHICAL ASPECTS OF THE STUDY ................................................................................. 42 
14 
QUALITY ASSURANCE AND QUALITY CONTROL ...................................................... 43 
REFERENCE LIST ............................................................................................................................. 45 
15 
APPENDICES ........................................................................................................................... 46 
 

Page 12 of 52 
 
4 
INTRODUCTION 
Nicotinamide adenine dinucleotide (NAD+) is one of the essential cofactors required for the proper 
function of living cells, and depletion in NAD has been correlated to ageing individuals as NAD 
is associated with oxidative stress and energy production (1).  Per the Population Reference Bureau 
(PRB), it is estimated that by the year 2060, the number of Americans over the age of 65 will 
double to over 98 million (2). As well, over the years, there has been a continuous rise in obesity 
within older Americans, reaching 44% for women and 36% for men in the age range of 65-74 (2). 
One of the most common chronic diseases that are accompanied by ageing and obesity diabetes. 
In 2016 the WHO reported that approximately 1.6 million deaths were attributed to diabetes. Half 
of these individuals had high blood glucose before the age of 70 (3). Hence it is crucial to actively 
control blood glucose and oxidative stress during one’s midlife stage.  
The investigating product RiaGev™ is the first and only commercially available product that 
contains Bioenergy Ribose® and vitamin B3 (4). It increases NAD+ in the body efficiently to 
promote healthy mitochondria, active immunity and cholesterol reduction. As a result, D-ribose is 
essential for healthy ageing (4). 
Bioenergy Ribose® is a 5-carbon carbohydrate (C5H10O5) called D-ribose designated as a  
Generally Recognized as Safe (GRAS) substance by the US Food and Drug Administration (FDA) 
(5). It is produced via the pentose phosphate pathway (PPP), which is fundamental for adenosine 
triphosphate (ATP) production (6). The PPP is a rate-limiting step that makes use of a short supply  
enzyme called glucose-6-phosphate dehydrogenase (G-6-PDH) (6). Supplementation of D-ribose 
can bypass the PPP and directly contribute to ATP production (6). In addition, to its function for 
ATP production D-ribose is a critical element of  deoxyribonucleic acid (DNA), ribonucleic acid 
(RNA), and acetyl coenzyme A (6). Provided there is a reduction in ATP production; ageing is 
frequently due to a decline in mitochondria function. Hence, cell function and integrity are 
compromised, leading to chronic cardiovascular conditions and fatigue (6). With active D-ribose 
supplementation, improvements have been noted in several pathological conditions such as 
chronic fatigue syndrome, fibromyalgia, and myocardial dysfunction (6). Furthermore, D-ribose 
demonstrated improvements in athletic performances by recovering ATP levels and repairing 
cellular damage (6).     
Vitamin B3 is an essential water-soluble vitamin known as either niacin, nicotinic acid, or 
nicotinamide. It is found in foods such as chicken, beef, fish, nuts, legumes, and grains (7). Also, 
vitamin B3 can be obtained from conversions of tryptophan in the body. Therefore, foods with 
tryptophan such as milk, eggs, meat and fish are another great source of vitamin B3 (7,8). Once 
vitamin B3 is consumed, it is converted into two different active forms called NAD+ or 
nicotinamide adenine dinucleotide phosphate (NADP) (7,8). NAD+ and NADP are essential for 
various metabolic redox processes with oxidized or reduced substrates. Cellular functions like 
genome integrity, gene expression, and cellular communication are carried out by NAD+ required 
enzymes (7). These required enzymes are also crucial for the production of ATP via energy transfer 
from carbohydrates, fats, and proteins (7). NADP is involved in fewer reactions than NAD+ such 
as cholesterol and fatty acid synthesis along with antioxidation (7). Lack of NAD+ has been 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 13 of 52 
 
associated with a variety of ageing related conditions such as metabolic syndrome, cardiovascular 
health, and cancer (1).  
This current randomized, double-blind, comparator-controlled, cross over study will investigate 
the efficacy and safety of RiaGev™ via evaluation of NAD+, glucose and insulin, in healthy adults 
of ages 36-65.   
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 14 of 52 
 
5 
STUDY OBJECTIVES 
The objective of this study is to evaluate the safety and efficacy of RiaGev™ in healthy adults  
 
Primary outcome: 
The change in whole blood NAD+ levels from baseline to day 8 when supplemented with RiaGev™ or 
comparator. 
 
Secondary outcomes: 
 
1. The change in serum glucose and insulin as assessed by an Oral Glucose Tolerance Test (OGTT) 
at t=0, 15m, 30, 45m, 60m, 90m and 2h after a 7-day supplementation with either RiaGev™ or 
comparator. 
2. The change in serum Glutathione/Glutathione disulfide (GSH/GSSG) ratio after a 7-day 
supplementation with either RiaGev™ or comparator  
3. The change in serum adenosine triphosphate/ adenosine monophosphate (ATP/AMP) ratio after a 
7-day supplementation with either RiaGev™ or comparator  
4. The change in salivary cortisol after a 7-day supplementation with either RiaGev™ or comparator  
5. The change in Checklist Individual Strength (CIS) Questionnaire outcome after a 7-day 
supplementation with either RiaGev™ or comparator.  
 
Safety outcomes: 
1. Incidence of pre-emergent and post-emergent adverse events when supplemented vital signs 
(blood pressure (BP) and heart rate (HR)) when supplemented  
2. clinical chemistry (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total 
bilirubin, creatinine, electrolytes (Na, K, Cl), fasting glucose and estimated glomerular 
filtration rate (eGFR))  
3. hematology (white blood cell (WBC) count with differential (neutrophils, lymphocytes, 
monocytes, eosinophils, basophils), red blood cell (RBC) count, hemoglobin, hematocrit, 
platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular 
hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell 
distribution width (RDW)  
 
(Optional) Exploratory Analysis: 
1. The change in NADH before and after exercise, measured with skin fluorescence, after a 7-day 
supplementation with either RiaGev™ or comparator.  
 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 15 of 52 
 
6 
STUDY DESIGN 
 
 
This will be a randomized, double-blind, comparator-controlled, crossover, safety and efficacy study 
conducted at Prism Clinical Research Clinic, Saint Paul, MN, USA, a KGK Science Inc. partner.  
The planned sample size for this study is 18, crossing over once is equivalent to 36 participants. To evaluate 
the outcomes, study assessments will be conducted as per the schedule of assessments in section 1.3 
 
Study Arm 
Number of Participants  
RiaGev™ !Comparator 
N = 9 
Comparator! RiaGev™  N = 9 
Total 
N = 18 
 
 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 16 of 52 
 
7 
SELECTION OF STUDY POPULATION 
Each participant must fulfill the inclusion criteria and not meet any of the exclusion criteria as described in 
Sections 7.1 and 7.2 respectively. 
 
Inclusion Criteria  
1. Healthy male and females between the ages of 35 and 65 years of age, inclusive 
2. BMI between 18.5 to 29.9 kg/m2, inclusive  
3. Female participant is not of child-bearing potential, defined as females who have undergone a 
sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, 
complete endometrial ablation) or have been post-menopausal (natural or surgically) for at least 
1 year prior to screening 
 
Or,  
Females of child-bearing potential must have a negative urine pregnancy test at screening and 
baseline and agree to use a medically approved method of birth control for the duration of the 
study. All hormonal birth control must have been in use for a minimum of three months. 
Acceptable methods of birth control include: 
• 
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho 
Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, 
Lunelle), or hormone implant (Norplant System) 
• 
Double-barrier method  
• 
Intrauterine devices 
• 
Non-heterosexual lifestyle or agrees to use contraception if planning on changing to 
heterosexual partner(s) 
• 
Vasectomy of partner at least 6 months prior to screening  
4. Healthy as determined by laboratory results, medical history, physical exam and EKG 
5. Agrees to avoid supplementation with tryptophan and vitamin B3 or its derivatives (niacin, 
nicotinic acid, niacinamide) one week prior to randomization and during the study 
6. Ability to complete maximal and submaximal exercise tests  
7. Agrees to maintain current diet and activity level throughout the study  
8. Agrees to comply to all study procedures  
9. Has given voluntary, written, informed consent to participate in the study 
10. Self-reported good sleeper at screening. Have a regular sleep cycle with a bedtime between 
the approximate hours of 9:00pm and 12:00am and regularly receive between 7-9 hours of 
sleep, and agrees to maintain this sleep schedule throughout the study  
 
 
Exclusion Criteria 
1. Women who are pregnant, breast feeding, or planning to become pregnant during the trial 
2. Allergy or sensitivity to investigational product’s ingredients or standard meal provided 
3. Current or ex-smokers within the past year 
4. Major surgery within the past 3 months which may impact the study outcomes to be assessed 
by the QI. 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 17 of 52 
 
5. Untreated/unresolved/uncontrolled cardiovascular disease. Participants with no significant 
cardiovascular event in the past 1 year and on stable medication may be included after 
assessment by the QI on a case by case basis  
6. Self reported current or pre-existing thyroid condition. Treatment on a stable dose medication 
for over 3 months will be reviewed on a case-by-case basis by the QI 
7. Current or history of hypertension.  
8. Type I or Type II diabetes 
9. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a 
follow up that is negative. Volunteers with cancer in full remission for more than five years 
after diagnosis are acceptable 
10. Self reported of any autoimmune disease or immune-compromised  
11. Self reported by subjects of being HIV or Hepatitis B/C positive 
12. History or currently with kidney and liver diseases assessed by QI on a case by case basis, 
with the exception of history of kidney stones symptom free for 1 year 
13. Known medical or psychological condition that, in the qualified investigator’s opinion, could 
interfere with study participation 
14. Significant gastrointestinal disease (examples include but are not limited to Celiac disease and 
inflammatory bowel disease) 
15. Self reported of bleeding disorders. 
16. Current diagnosis of gout within past three months as per the QI’s assessment 
17. Clinically significant abnormal laboratory results at screening as assessed by QI 
18. Current use of prescribed medications or over the counter supplements that may interfere with 
the IP assessed by QI (See Section 7.3) 
19. Alcohol consumption of >2 standard drinks/day or >14 drinks/week 
20. Alcohol or drug abuse within the past 12 months 
21. Use of medical marijuana 
22. Frequent use of recreational drugs within 6 months of baseline assessed as per QI 
23. Planned blood donation during or within 30 days following conclusion of clinical trial 
24. Participation in other clinical research trials 30 days prior to baseline  
25. Participants that are cognitively impaired and/or who are unable to give informed consent 
26. Any other active or unstable medical condition, that, in the opinion of the QI, may adversely 
affect the participant's ability to complete the study or its measures or pose significant risk to 
the participant. 
 
 
 
Concomitant Medications  
Participants who are taking any prescribed medications that are considered not to affect the study 
outcomes must agree to maintain their current dosing regimen during the study unless otherwise 
recommended by their family physician.  
7.3.1 
Prescribed Medications 
Participants on the following concurrent prescribed medications and/or treatments will be excluded during 
enrollment unless they have been taken off these therapies by their family physician. In the latter event, 
the frequency of use and/or dosage may be considered by the QI on a case by case basis prior to 
recommending an appropriate washout or their enrollment in the study.  

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
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1. Warfarin (anticoagulant) 
2. Clonidine and other antihypertensive drugs 
3. Selective estrogen receptor modulator  
• 
Tamoxifen 
• 
Raloxifene  
• 
Toremifene 
4. Antidepressants like Selective serotonin re-uptake inhibitors (SSRI)  
• 
Citalopram 
• 
Fluoxetine 
• 
Fluvoxamine 
• 
Paroxetine 
• 
Sertraline  
5. Oral corticosteroids (immunosuppressant) 
6. Isoniazid 
7. Pyrazinamide 
7.3.2 
Over-the-counter Medications, Supplements  
Participants who are currently consuming the following supplements will not be allowed to participate 
unless willing to undergo the specified washout period prior to their baseline visit and agree not to take 
the supplements during the study. Other supplements will require a case-by-case assessment by the QI 
based on dose and/or frequency of use to determine adequate washout.  
1. Vitamin B3 derivatives supplements (7-day washout) 
2. Tryptophan supplements (7-day washout) 
3. Chromium supplements (7-day washout) 
 
 
Early Withdrawal 
Personal reasons: 
As stated in the Informed Consent Form, a participant may withdraw from the study for any reason at any 
time. 
Removal by Qualified Investigator: 
Participant discontinuation should be considered at the discretion of the qualified investigator.  The 
circumstances of any discontinuation must be documented in detail in the participant file and final report.  
If possible, the evaluations planned for the end of treatment will be carried out at the time when the 
participant is withdrawn from the study.  A participant leaving the study prematurely will NOT be 
replaced by another.  It is understood by all concerned that an excessive rate of withdrawals can render 
the study un-interpretable, thus unnecessary withdrawal of participants should be avoided. 
Criteria for removal of participants from the study includes: 
Clinical reasons 
A participant may be withdrawn from the study if, in the opinion of the qualified investigator, it is not in 
the participant's best interest to continue.  Any participant who experiences a serious adverse event (SAE) 
may be withdrawn from the trial at the discretion of the qualified investigator.  A participant will also be 

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withdrawn due to adverse events causing clinically significant illness or the need for prohibited 
medication(s) during the trial. Any female participant who becomes pregnant during the course of the trial 
will be withdrawn.   
Protocol violation 
Any participant found to have entered this study in violation of the protocol will be discontinued from the 
study at the discretion of the qualified investigator.  This will include any participant found to have been 
inappropriately enrolled (did not meet eligibility criteria).  Participant non-compliance includes failure to 
show up for study visits, failure to take the investigational product as directed, or refusal to undergo study 
visit procedures.  Participants who are found to be taking prohibited medications or supplements without 
the knowledge of the qualified investigator will also be withdrawn. Any major protocol deviations (i.e. 
those that increase the risk to participants and/or compromise the integrity of the study or its results) will 
result in participant discontinuation. 
 
 

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8 
INVESTIGATIONAL PRODUCT 
 
Manufacturing and Storage 
The investigational product will be provided to Prism Clinical by the Sponsor.  The investigational 
product will be carefully stored at the study site in a lockable, limited access area, accessible only to study 
team personnel in compliance with pertinent regulations.  Only authorized persons will have access to the 
investigational product. In an ambient condition the product will be stored at room temperature and will 
not be exposed to direct sunlight or heat. The product and placebo will be provided in single use sachet, 
both blinded in label. The investigational products will be kept in a locked investigational product storage 
room at Prism Clinical on receipt.  An accountability log will be kept for the investigational products.  
All unused investigational product will be returned to the study sponsor by Prism Clinical (at the 
sponsor’s expense) or destroyed on receipt of written confirmation from the sponsor at study closeout 
(within one month of last participant visit). 
Manufactured by: 
 
Bioenergy Life Science, Inc.  
 
Labelling and Coding 
The investigational product will be labeled according to the requirements of ICH-GCP guidelines and 
applicable local regulatory guidelines. Investigational product will be randomized and coded by an 
unblinded person at KGK Science Inc. who is not involved in data collection or analysis.  
 
Investigational Product (RiaGev ™) 
Dietary Ingredient 
Quantity (2 g/sachet, in 3 capsules) 
Bioenergy Ribose® (D-ribose) 
1280mg 
Vitamin B3 (Nicotinamide) 
240mg 
Non-medical ingredients: 480mg Palm oil  
 
Comparator 
Ingredients: 480mg Palm oil and 1280mg Dextrose, packaged in 3 capsules in a sachet 
 
Directions 
Participants will be instructed to take two doses of the IP daily, once in the morning and once in the 
evening. Each dose will be 3 capsules, one dose will be administered immediately before breakfast and 
the other dose will be administered immediately before dinner. In both study periods, on day 1 only the 
evening dose will be administered and on day 8 only morning dose will be administered. The Clinic staff 
will instruct participants to save all unused and open packages and return them to Prism Clinical for a 

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determination of compliance. If a dose is missed participants are instructed to consume the missed dose 
anytime on the same day, except at bedtime. Participants will be advised not to exceed two servings daily. 
 
Randomization 
A randomization schedule will be created and provided to the Investigator indicating the order of 
randomization. Each participant will be assigned a randomization code according to the order of the 
randomization list generated using www.randomization.com. Enrolled participants will be randomized to 
the different treatment arms at day 1 in a double-blind manner.  
 
Unblinding and Allocation Concealment 
Unblinding should not occur except in the case of emergency situations. In the event that a serious 
adverse event occurs, for which the identity of the investigational product administered is necessary to 
manage the participant’s condition, the treatment received by the participant will be unblinded and the 
investigational product identified.  Concealment of the allocation of treatment will be employed through 
the use of opaque sealed envelopes, each labeled with a randomization number. Each envelope will 
contain information regarding the treatment associated with each randomization number. These envelopes 
will be readily available for the investigator to open in the event that it becomes necessary to know which 
product a participant is taking for the sake of the participant health care. The sponsor must be notified of 
any unblinding within 24 hours. Details of participants who are unblinded during the study will be 
included in the Final Report. 
 
 

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9 
STUDY ASSESSMENTS 
* At the discretion of the Qualified Investigator, any participants falling outside of the screening window 
(Day -45 to Day -1) due to scheduling issues will be asked to repeat eligibility/screening procedures prior 
to randomization at baseline. 
 
Visit 1 – Screening (Day -45 to Day -14) * 
Participants will show up at the clinic in a fasted state (8h) for visit 1. At screening, an informed consent 
form will be given to the potential volunteer.  They will be required to read the information and will be 
given the opportunity to seek more information if needed, or provided with the option of taking the 
consent form home to review prior to making their decision. If agreeable, the volunteer will sign the 
consent form and receive a duplicate of the signed copy. Once consent has been obtained, the screening 
visit will proceed. Each volunteer will be sequentially assigned a screening number to be entered in the 
screening and enrollment log.   
Screening assessments include: 
1. Review medical history, concomitant therapies and current health status  
2. Assess inclusion and exclusion criteria  
3. Urine pregnancy test for female potential participants that are of child-bearing potential 
4. Seated resting blood pressure and heart rate measurements 
5. Weight and height measurements (BMI calculation) 
6. Physical exam  
7. EKG  
8. Collect fasted blood samples for the analysis of Complete Blood Count (CBC), HbA1c, 
electrolytes (Na, K, Cl), fasting glucose, eGFR, creatinine, AST, ALT, and total bilirubin  
9. Complete maximum heart rate treadmill test (Section 9.12.6)  
10. Dispense 3-Day Food Record and sleep diary 
11. Dispense salivary collection kit and instruct participants on use (Section 9.12.5)   
The next visit will be scheduled for potentially eligible participants for baseline (Day 1). 
Reminders for participants prior to their next in-clinic visit: 
1. Abide by instructions for medications as per Section 7.3.1 and OTC medications, supplements, 
and food/drinks as per Section 7.3.2 
2. Complete and return the Food record for the three days prior to baseline visit for review  
3. Maintain current level of physical activity and maintain and record sleep schedule in diary 
4. Participants will be advised follow the dietary guidelines (see appendix 15.3) 
5. Participants will collect baseline salivary cortisol the morning of their Baseline Visit (Section 
9.12.5)  
 
Run-in period – 2 weeks (Day -13 to Day 0)   
Participants will undergo a 14 days run-in period. 

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Participants are reminded to follow the dietary guidelines 15.3, avoid the consumption of the medications 
and supplements as per 7.3.1 and 7.3.2, collect saliva the morning of the next in-clinic visit, maintain 
current level of physical activity and maintain and record sleep schedule.  
 
Visit 2 - Baseline (period 1- Day 1+1 Day) 
Eligible participants will return to the clinic fasted (8h) with completed saliva kit, sleep diary and food 
diary for baseline assessments. 
Baseline (Day 1) assessments include: 
1. Return completed salivary cortisol collection kit  
2. Review concomitant therapies 
3. Assess inclusion and exclusion criteria  
4. Urine pregnancy test for female potential participants that are of child-bearing potential 
5. Seated resting blood pressure and heart rate measurements 
6. Review AEs 
7. Weight measurements (BMI calculation) 
8. Physical exam  
9. Randomization of eligible participants  
10. Collect Food Record and sleep diary for review  
11. Collect blood sample at T=0 (pre-meal) for fasting serum glucose, insulin 
12. Standardized meal provided (see Appendix 15.2) 
13. Collect post-meal blood sample for serum glucose and insulin analysis at: 
a. T= 15min 
b. T= 30min 
c. T= 45min 
d. T= 60min 
e. T= 90min 
f. T= 2hrs 
14. Collect blood sample at T=2 hours (post-meal) for NAD+ 
15. (Optional) Measure NADH with skin fluorescence  
16. Complete treadmill exercise protocol (Section 9.12.7) 
17. (Optional) Measure NADH with skin fluorescence  
18. Collect blood sample for GSH/GSSG and ATP/AMP analysis  
19. Administer CIS questionnaire  
20. Dispense investigational product and instruct participants on use. Participants will be instructed 
to take their first dose of the investigational product in evening of Day 1.  
21. Dispense saliva collection kit  
22. Dispense 7-Day Food Record and subject sleep and treatment diary 
 
The next visit will be scheduled for visit 3 (period 1- Day 3) 
Reminders for participants prior to their next in-clinic visit: 
1. Abide by instructions for medications as per Section 7.3.1 and OTC medications, supplements, 
and food/drinks as per Section 7.3.2 
2. Maintain current level of physical activity and sleep schedule  

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3. Complete and return the food record, sleep and treatment diary  
4. Participants will be advised to follow the dietary guidelines (see appendix 15.3) 
5. Collect saliva in the morning 15 minutes after waking and prior to consumption of food  
6. Return to clinic one hour after consuming investigational product/placebo and breakfast on the 
next visit day 
 
Visit 3 - (period 1- Day 3+1 Day) 
Participants will return to the clinic one hour after consuming investigational product/placebo for Visit 3 
assessments with unused investigational product, completed Subject sleep and treatment diary, saliva kit 
and food records. 
Visit 3 assessments include: 
1. Review concomitant therapies 
2. Seated resting blood pressure and heart rate measurements 
3. Weight measurements (BMI calculation) 
4. Return unused investigational product in the original packaging and remnants and calculate 
compliance by counting the returned unused investigational product 
5. Return saliva collection kit  
6. Review AEs 
7. Collect food record and subject sleep and treatment diary for review 
8. Collect blood sample for NAD+ analysis  
9. Administer CIS questionnaire  
10. Re-dispense 7-Day Food Record  
11. Dispense Subject sleep and treatment Diary 
12. Dispense new saliva collection kit  
13. Dispense new investigational product and instruct participants on use 
The next visit will be scheduled for visit 4 (period 1- Day 5) 
Reminders for participants prior to their next in-clinic visit: 
1. Abide by instructions for medications as per Section 7.3.1 and OTC medications, supplements, 
and food/drinks as per Section 7.3.2 
2. Maintain current level of physical activity and sleep schedule 
3. Complete and return the food record and sleep and treatment diary  
4. Participants will be advised to follow the dietary guideline (see Appendix 15.3) 
5. Collect saliva in the morning 15 minutes after waking and prior to consumption of food  
6. Return to clinic one hour after consuming investigational product/placebo and breakfast on the 
next visit day 
 
 
Visit 4 – (period 1- Day 5+1 Day) 
Participants will return to the clinic one hour after consuming investigational product/placebo for Visit 4 
assessments with unused investigational product, completed Subject sleep and treatment diary, saliva kit 
and food records. 

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Visit 4 assessments include: 
1. Review concomitant therapies 
2. Seated resting blood pressure and heart rate measurements 
3. Weight measurements (BMI calculation) 
4. Return unused investigational product in the original packaging and remnants and calculate 
compliance by counting the returned unused investigational product 
5. Return saliva collection kit  
6. Review AEs 
7. Collect food record and subject sleep and treatment diary for review  
8. Collect blood sample for NAD+ analysis 
9. Administer CIS questionnaire  
10. Re-dispense 7-Day Food Record  
11. Dispense Subject sleep and treatment Diary 
12. Dispense saliva collection kit  
13. Dispense new investigational product and instruct participants on use 
The next visit will be scheduled for visit 5 (period 1- Day 8) 
Reminders for participants prior to their next in-clinic visit: 
1. Abide by instructions for medications as per Section 7.3.1 and OTC medications, supplements, 
and food/drinks as per Section 7.3.2 
2. Maintain current level of physical activity and sleep schedule 
3. Complete and return the food record and sleep and treatment diary 
4. Participants will be advised to follow the dietary guideline (see appendix 15.3) 
5. Collect saliva in the morning 15 minutes after waking and prior to consumption of food  
6. Return to clinic in a fasting state (8h), without taking IP on the next visit day 
 
Visit 5 - (period 1- Day 8+1 Day) 
Participants will return to the clinic fasted (8h) for Visit 5 assessments with unused investigational 
product, completed Subject sleep and treatment diary, saliva kit, and food records. 
Visit 5 (Day 6) assessments include: 
1. Review concomitant therapies 
2. Seated resting blood pressure and heart rate measurements 
3. Weight measurements (BMI calculation) 
4. Return unused investigational product in the original packaging and remnants and calculate 
compliance by counting the returned unused investigational product 
5. Return saliva collection kit  
6. Review AEs 
7. Collect Food Record and Subject sleep and treatment diary for review  
8. Collect blood sample at T=0 (pre-meal) for fasting serum glucose, insulin, CBC, electrolytes 
(Na, K, Cl), eGFR, creatinine, AST, ALT, total bilirubin 
9. Administer the investigational product 
10. Standardized meal provided (see Appendix 15.2) 
11. Collect post-meal blood sample for serum glucose and insulin analysis at: 
a. T= 15min 

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b. T= 30min 
c. T= 45min 
d. T= 60min 
e. T= 90min 
f. T= 2 hours  
12. Collect blood sample at T=2 hours (post-meal) for NAD+ 
13. (Optional) Measure NADH with skin fluorescence  
14. Complete treadmill exercise protocol (Section 9.12.7)  
15. (Optional) Measure NADH with skin fluorescence  
16. Collect blood sample for GSH/GSSG and ATP/AMP 
17. Administer CIS questionnaire 
18. Dispense 7-Day Food Record and Subject sleep and treatment Diary 
19. Dispense saliva collection kit  
 
The next visit will be scheduled for visit 6 (period 2- Day 1) 
Reminders for participants prior to their next in-clinic visit: 
1. Abide by instructions for medications as per Section 7.3.1 and OTC medications, supplements, 
and food/drinks as per Section 7.3.2 
2. Maintain current level of physical activity and sleep schedule 
3. Complete the food record for three days before next study visit and return the food record and 
sleep and treatment diary 
4. Participants will be advised to follow the dietary guideline (see appendix 15.3) 
5. Participants will collect baseline salivary cortisol the morning of their Baseline Visit (Section 
9.12.5)  
 
Washout period (Day 9 to Day 15+3 Days) 
Participants will undergo a 7-day washout prior to visit 6. 
Participants are reminded to follow the dietary guidelines 15.3, avoid the consumption of the medications 
and supplements as per 7.3.1 and 7.3.2, collect saliva the morning of the next in-clinic visit, and maintain 
current level of physical activity and maintain and record sleep schedule.   
 
 
Visit 6 – Baseline (period 2- Day 1+1 Day) 
Participants will return to the clinic fasted (8h) for Visit 6 assessments with completed Subject sleep and 
treatment diary, saliva kit and food records. 
Visit 6 (Day 1) assessments include: 
1. Review concomitant therapies 
2. Seated resting blood pressure and heart rate measurements 
3. Weight measurements (BMI calculation) 
4. Collect Food Record and Subject sleep and treatment diary for review  

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5. Return saliva collection kit  
6. Review AEs 
7. Collect blood sample at T=0 (pre-meal) for fasting serum glucose, insulin, CBC, electrolytes 
(Na, K, Cl), eGFR, creatinine, AST, ALT, total bilirubin 
8. Standardized meal provided (see Appendix 15.2) 
9. Collect post-meal blood sample for serum glucose and insulin analysis at: 
a. T= 15min 
b. T= 30min 
c. T= 45min 
d. T= 60min 
e. T= 90min 
f. T= 2hrs 
10. Collect blood sample at T=2 hours (post-meal) for NAD+ 
11. (Optional) Measure NADH with skin fluorescence  
12. Complete treadmill exercise protocol (Section 9.12.7) 
13. (Optional) Measure NADH with skin fluorescence  
14. Collect blood sample for GSH/GSSG and ATP/AMP analysis  
15. Administer CIS questionnaire  
16. Dispense 7-Day Food Record and subject sleep and treatment diary 
17. Dispense saliva collection kit  
18. Dispense new investigational product and instruct participants on use 
 
The next visit will be scheduled for visit 7 (period 2- Day 3) 
Reminders for participants prior to their next in-clinic visit: 
1. Abide by instructions for medications as per Section 7.3.1 and OTC medications, supplements, 
and food/drinks as per Section 7.3.2 
2. Maintain current level of physical activity and sleep schedule 
3. Collect saliva in the morning 15 minutes after waking and prior to consumption of food  
4. Complete and return the food record and sleep and treatment diary  
5. Participants will be advised to follow the dietary guideline (see appendix 15.3) 
6. Return to clinic one hour after consuming investigational product/placebo on the next visit day  
 
Visit 7 - (period 2- Day 3+1 Day) 
Participants will return to the clinic for Visit 7 assessments one hour after consuming investigational 
product/placebo with unused investigational product, completed Subject sleep and treatment diary, saliva 
kit and food records. 
Visit 7 assessments include: 
1. Review concomitant therapies 
2. Seated resting blood pressure and heart rate measurements 
3. Weight measurements (BMI calculation) 
4. Return unused investigational product in the original packaging and remnants and calculate 
compliance by counting the returned unused investigational product 
5. Return saliva collection kit  

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6. Review AEs 
7. Collect food record and subject sleep and treatment diary for review  
8. Collect blood sample for NAD+ analysis   
9. Administer CIS questionnaire 
10. Re-dispense 7-Day Food Record  
11. Dispense Subject sleep and treatment diary 
12. Dispense saliva collection kit 
13. Dispense new investigational product and instruct participants on use 
The next visit will be scheduled for visit 8 (period 2- Day 5) 
Reminders for participants prior to their next in-clinic visit: 
1. Abide by instructions for medications as per Section 7.3.1 and OTC medications, supplements, 
and food/drinks as per Section 7.3.2 
2. Maintain current level of physical activity and sleep schedule 
3. Collect saliva in the morning 15 minutes after waking and prior to consumption of food  
4. Complete and return the food record and sleep and treatment diary  
5. Participants will be advised to follow the dietary guideline (see appendix 15.3) 
6. Return to clinic one hour after consuming investigational product/placebo on the next visit day  
 
Visit 8 - (period 2- Day 5+1 Day) 
Participants will return to the clinic for Visit 8 assessments one hour after consuming investigational 
product/placebo with unused investigational product, completed Subject sleep and treatment diary, saliva 
kit, and food records. 
Visit 8 assessments include: 
1. Review concomitant therapies 
2. Seated resting blood pressure and heart rate measurements 
3. Weight measurements (BMI calculation) 
4. Return unused investigational product in the original packaging and remnants and calculate 
compliance by counting the returned unused investigational product 
5. Return saliva collection kit 
6. Review AEs 
7. Collect food record and subject sleep and treatment diary for review  
8. Collect blood sample for NAD+ analysis   
9. Administer CIS questionnaire 
10. Re-dispense 7-Day Food Record  
11. Dispense Subject sleep and treatment diary 
12. Dispense saliva kit  
13. Dispense new investigational product and instruct participants on use 
The next visit will be scheduled for visit 9 (period 2- Day 8) 
Reminders for participants prior to their next in-clinic visit: 
1. Abide by instructions for medications as per Section 7.3.1 and OTC medications, supplements, 
and food/drinks as per Section 7.3.2 

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2. Maintain current level of physical activity and sleep schedule 
3. Collect saliva in the morning 15 minutes after waking and prior to consumption of food  
4. Complete and return the food record and sleep and treatment diary  
5. Participants will be advised to follow the dietary guideline (see appendix 15.3) 
6. Return to clinic in a fasting state (8h), without taking IP on the next visit day 
 
 
Visit 9 – End of the Study (period 2- Day 8+1 Day) 
Participants will return to the clinic fasted (8h) for Visit 9 assessments with unused investigational 
product, completed Subject sleep and treatment diary, saliva kit, and food records. 
Visit 9 assessments include: 
1. Review concomitant therapies 
2. Seated resting blood pressure and heart rate measurements 
3. Weight measurements (BMI calculation)  
4. Return unused investigational product in the original packaging and remnants and calculate 
compliance by counting the returned unused investigational product 
5. Physical Exam  
6. Collect Food Record and Subject sleep and treatment diary for review  
7. Return saliva collection kit 
8. Review AEs 
9. Collect blood sample at T=0 (pre-meal) for fasting serum glucose, insulin, Complete Blood 
Count (CBC), electrolytes (Na, K, Cl), eGFR, creatinine, AST, ALT, total bilirubin 
10. Administer the investigational product 
11. Standardized meal provided (see appendix 15.2) 
12. Collect post-meal blood sample for serum glucose and insulin analysis at: 
a. T= 15min 
b. T= 30min 
c. T= 45min 
d. T= 60min 
e. T= 90min 
f. T= 2hrs  
13. Collect blood sample at T=2 hours (post-meal) for NAD+ 
14. (Optional) Measure NADH with skin fluorescence  
15. Complete treadmill exercise protocol (Section 9.12.7)  
16. (Optional) Measure NADH with skin fluorescence  
17. Collect blood sample for GSH/GSSG and ATP/AMP Analyses   
18. Administer CIS questionnaire 
 
Clinical Assessments and Procedures 
Calculations or measurements of specific parameters are required, as indicated in the schedule of 
assessments. Instructions for determining these parameters are provided in the following sections. 

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9.12.1 Height and Weight 
Weight measurements will be performed with shoes removed and bladder empty.  Participants will be 
weighed on the same scale at all visits. 
At least two separate measurements will be taken at each visit.  If the two measurements are more than 
0.5 kg (1.1 lbs) apart, a third measurement will be taken. The two closest values will be selected and 
entered in the database.   
Measurement of height will be performed with the participant’s shoes removed.  The participant’s knees 
will be straightened, and head held upright. 
 
9.12.2 Blood Pressure and Heart Rate 
In-office, seated, resting blood pressure assessment:  
The participant should be seated comfortably with their back supported and the upper arm bared without 
restrictive clothing. Feet should be flat on the floor and legs will not be crossed. The participant will rest 
in this position for at least five minutes prior to the first reading.  
At screening: 
Seated blood pressure will be checked in both arms and if different the arm with the higher systolic blood 
pressure reading will be taken for measurements. If the systolic blood pressure is the same in both arms, 
the arm with the higher diastolic blood pressure will be used. If both are equal, then the left arm will be 
used. In the chosen arm, a second measurement will be taken at least 1 minute from the first 
measurement. If a difference of more than 8 mmHg exists between the two readings a third reading will 
be taken. An average of the two lowest readings from the chosen arm will be taken for the determination 
of inclusion into the study. As per the QI’s opinion, a high office blood pressure should be rechecked 
manually after the participant is given a glass of water and is seated for 15 min. Also, participant should 
be queried about their usual blood pressure.  
The arm chosen for use at the initial visit will be documented in the study file and used in all subsequent 
visits.  
At study visits:  
Once enrolled in the study, BP will be measured in the chosen arm. Three readings will be made, 
averaged and recorded in the chart. 
Heart Rate (beats/min) will be measured using the reading on the automated blood pressure monitor, or 
manually by the clinical coordinator placing their index finger on the participant's radial artery while 
observing a timer and counting the number of beats over 30 seconds and then multiplying the number by 
two. This is repeated for a total of three measurements. 
 

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9.12.3 Blood Sample Collection 
Blood samples will be collected during visit 2, visit 5, visit 6, and visit 9 as per the procedures for 
outlined below.  
Participants will be placed in a comfortably seated position with their arm fully extended and supported 
by a pillow. Aa tourniquet will be applied to the desired arm 3-4 inches above the elbow or 4-5 inches 
above the wrist to facilitate locating a vein. Once chosen, the site will be cleansed with 70% isopropyl 
alcohol, allowed to dry, and the IV catheter will be inserted piercing the skin and into the vein to the 
desired depth. With the catheter in place, the positive displacement connector will be attached to the 
blood collection hub, a patch will be placed over the entire system, and the access device will be 
connected to the positive displacement connector. The vacutainer tube will then be allowed to fill as per 
the Order of Draw and Fill Level Chart. When required, the filled tube will be disengaged, and another 
tube engaged. After disengaging, each tube will be inverted gently a number of times as per the Order of 
Draw and Fill Level Chart. This collection process will be repeated for the remaining blood collection 
time points until the number of blood draws had been satisfied.   The IV catheter will be kept patent with 
a saline.  To remove the IV catheter, the patch will be peeled back, and the tape will be peeled back to 
ensure the system is not removed from the connector. A cotton ball will be placed at the puncture site, and 
the system removed in a swift motion. Pressure will be applied to the site for a minimum of 30 seconds.  
Once the clotting has occurred, a bandage/cotton ball and tape will be applied over the puncture site. 
Alternatively, if blood drawn via the catheter is unsuccessful, direct venipuncture will be conducted. 
Samples will be collected as per the following procedures for venipuncture at visit 1, visit 3, visit 4, visit 
7 and visit 8. 
Participants will be placed in a comfortably seated position with their arm fully extended and supported 
by a pillow. All appropriate tubes, needle, alcohol and cotton balls will be retrieved. A tourniquet will be 
applied to the desired arm 3-4 inches above the elbow or 4-5 inches above the wrist and the participant 
will be requested to open and close their fist a few times to facilitate locating a vein. The vein will be 
gently pressed to determine its direction, approximate size and depth. The tourniquet will be removed, 
and the chosen site will be cleansed with 70% isopropyl alcohol and cotton ball or alcohol pad. The site 
will be allowed to dry, and the tourniquet will be reapplied, and the participant will be required to make a 
tight fist. The vacutainer system (needle placed in the holder) will be held and the vein will be anchored. 
The needle will be inserted into the skin and vein at 30o angle. The vacutainer tube will then be allowed to 
fill as per the Order of Draw and Fill Level Chart. When required, the filled tube will be disengaged, and 
another tube engaged. After disengaging, each tube will be inverted gently a number of times as per the 
Order of Draw and Fill Level Chart. The tourniquet will be removed when the last collection tube is half 
full. A cotton ball will be placed over the site, and the needle will be removed in a swift motion. Pressure 
will be applied to the site for a minimum of 30 seconds. Once the clotting has occurred, a bandage/cotton 
ball and tape will be applied over the puncture site 
9.12.4 Checklist Individual Strength Questionnaire (CIS) Questionnaire  
The Checklist Individual Strength Questionnaire is a validated questionnaire for healthy working 
population (Appendix 15.5). This is a 20 items questionnaire scored on a 7-point scale measuring 
subjective fatigue experience, reduced concentration, reduced motivation and reduced physical activity 
level. The Questionnaire will be administered to participants on visit 2 to visit 8.  

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9.12.5 Saliva Sample Collection  
Participants will collect salivary cortisol samples using the Salivette collection device.  Saliva sample will 
be collected within 15 minutes of waking and prior to eating on the mornings of all visits, except 
screening (Visit 1). To ensure proper collection, participants will be provided instruction by Prism clinical 
site. 
 
9.12.6 Maximum Heart Rate Treadmill Test   
Participants will complete a graded treadmill test following a ramped Bruce protocol (9,10) at their 
screening visit (Appendix 15.4). Participants will continue to advance stages until volitional exhaustion 
by the participant. Throughout the test, participants heart rate will be monitored and recorded with a chest 
strap heart rate monitor. Successful competition of the test will be achieving 85% or greater of age 
predicted maximum heart rate (220-age) (9).  
 
9.12.7 Treadmill Exercise  
Participants will determine their max heart rate (HR) in the clinic at visit 1 (screening, Day 0) via graded 
treadmill test with a chest strap heart rate monitor (Section 9.12.6).  Eligible participants will return and 
exercise on the treadmill at visit 2 (period 1, Day 1), visit 5 (period 1, Day 8), visit 6 (period 2, Day 1), 
and visit 9 (period 2, Day 8). On the day of the exercise, participants will be instructed to warm up on the 
treadmill first for five minutes at a leisurely walking pace. When the participants are ready, speed will be 
increased to 60% of participant’s HRmax with 5% grade incline and they will be instructed to walk on the 
treadmill for 30 minutes or until exhaustion (11).  
9.12.8 Skin Fluorescence (Optional)  
The AngioExpert device may be optionally employed to evaluate the 460 nm fluorescence of the skin in 
response to activation by the 340nm UV light. The wavelength of 340 nm emitted in the FMSF method is 
only specific to NADH, thus no other substance in the skin can be excited. The AngioExpert will be used 
to continuously measure the 460 nm fluorescence from the most superficial skin cells in the forearm at 
rest, then during controlled ischemia triggered by total occlusion of the brachial artery by the brachial 
blood pressure cuff, and, finally, during reperfusion after deflation of the blood pressure cuff  (12).  
 
9.12.9 Food Records  
Participants will be asked to record their food consumption during the study. This data will be used to 
calculate and analyze their daily calories, macronutrient and micronutrient intake throughout the study 
using a software called Nutritics. The food records will be reviewed by trained staff at the visits and 
participants will be counseled with dietary suggestions as required. All participants will be provided with 
instructions on how to complete their food records.  
 

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Compliance 
Compliance will be assessed by counting the returned unused study product at each visit.  Compliance is 
calculated by determining the number of dosage units taken divided by the number of dosage units 
expected to have been taken multiplied by 100. 
𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑑𝑜𝑠𝑎𝑔𝑒 𝑢𝑛𝑖𝑡𝑠 𝑡𝑎𝑘𝑒𝑛
𝑛𝑢𝑚𝑏e𝑟 𝑜𝑓 𝑑𝑜𝑠𝑎𝑔𝑒 𝑢𝑛𝑖𝑡𝑠 𝑒𝑥𝑝𝑒𝑐𝑡𝑒𝑑 𝑡𝑜 ℎ𝑎𝑣𝑒 𝑏𝑒𝑒𝑛 𝑡𝑎𝑘𝑒𝑛 × 100% 
In the event of discrepancy between the information in the treatment diary and the amount of study 
product returned, use will be based on the product returned unless an explanation for loss of product has 
been provided. Participants found to have a compliance of <80% or >120% will be counseled.  A 
compliance of <70% or >130% will be considered as non-compliant and any participant demonstrating 
non-compliance for two consecutive visits will be withdrawn from the study. 
 
 
Laboratory Analyses 
Blood samples will be drawn from the participants at screening (Visit 1, Day 0), baseline (Visit 2, Day 1), 
V3, V4, V5, V6, V7, V8, and at the End of Study visit (V9) as indicated in the schedule of assessments.   
Protection of subject confidentiality will extend to all data generated from the assaying of these samples.  
These samples will be alphanumerically coded and the persons performing the analysis will not be aware 
of the subject’s identity or the product they received. 
At screening (Visit 1), 8 hour fasting: 
1. Two EDTA vacutainer tubes to generate whole blood for: 
a. CBC analysis  
b. Hb-A1c analysis  
 
2. One SST vacutainer tube to generate serum for: 
a. electrolytes (Na, K, Cl), fasting glucose, eGFR, creatinine, AST, ALT, and total bilirubin 
analysis  
At baseline (Visit 2) 
1. One BD vacutainer tube to generate whole blood for: 
a. NAD+  
 
2. Two SST vacutainer tubes to generate Pre-Prandial serum for: 
a. Fasting Glucose analysis  
b. Fasting Insulin analysis  
 
3. One BD vacutainer tube to generate whole blood for:  
a. ATP/AMP analysis  
b. GSH/GSSG analysis 
 
4. Twelve SST vacutainer tubes to generate serum for: 

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a. Fasting Glucose analysis (one per time point tube) 
b. Fasting Insulin analysis (one per time point tube) 
 
Visit 3: 
1. One BD vacutainer tubes to generate whole blood for: 
a. NAD+ 
Visit 4: 
1. One BD vacutainer tubes to generate whole blood for: 
a. NAD+ 
Visit 5  
1. One BD vacutainer tube to generate whole blood for: 
a. NAD+ 
 
2. Two SST vacutainer tubes to generate Pre-Prandial serum for: 
a. electrolytes (Na, K, Cl), eGFR, creatinine, AST, ALT, and total bilirubin, fasting 
Glucose and Fasting Insulin analysis  
 
3. One BD vacutainer tube to generate whole blood for:  
a. ATP/AMP analysis  
b. GSH/GSSG analysis 
 
4. Twelve SST vacutainer tube to generate Post-Prandial serum for: 
a. Fasting Glucose analysis (one per time point tube) 
b. Fasting Insulin analysis (one per time point tube) 
 
5. One EDTA vacutainer tubes to generate whole for: 
a. CBC analysis  
Visit 6 
1. One BD vacutainer tube to generate whole blood for: 
a. NAD+  
1. Two SST vacutainer tubes to generate Pre-Prandial serum for: 
a. electrolytes (Na, K, Cl), eGFR, creatinine, AST, ALT, and total bilirubin, fasting 
Glucose and Fasting Insulin  
2. Twelve SST vacutainer tube to generate Post-meal serum for: 
a. Fasting Glucose analysis (one per time point tube) 
b. Fasting Insulin analysis (one per time point tube) 
 
3. One BD vacutainer tube to generate whole blood for:  
a. ATP/AMP analysis  
b. GSH/GSSG analysis 
 

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4. One EDTA vacutainer tubes to generate whole blood for: 
a. CBC analysis  
Visit 7 
1. One BD vacutainer tube to generate whole blood for: 
a. NAD+  
Visit 8 
1. One BD vacutainer tube to generate whole blood for: 
a. NAD+  
At the end of the study (Visit 9)  
1. One BD vacutainer tube to generate whole blood for: 
a. NAD+  
 
2. Two SST vacutainer tube to generate Pre-Prandial serum for: 
a. electrolytes (Na, K, Cl), eGFR, creatinine, AST, ALT, and total bilirubin, fasting 
Glucose and Fasting Insulin analysis  
 
3. One BD vacutainer tube to generate whole blood for:  
a. ATP/AMP analysis  
b. GSH/GSSG analysis 
 
4. Twelve 8.5mL SST vacutainer tube to generate Post-Prandial serum for: 
a. Fasting Glucose analysis (one per time point tube) 
b. Fasting Insulin analysis (one per time point tube) 
 
5. One EDTA vacutainer tubes to generate whole blood for: 
a. CBC analysis  
The total blood volume collection for the laboratory assessments listed above will be approximately 250 
mL, over the period from screening to end of study (approximately 20 days). At any study visit, blood 
loss per volunteer is not expected to exceed 131.5 mL. Additional blood samples may be collected during 
the course of the study in order to perform or repeat laboratory tests outlined in the Schedule of 
Assessments if needed.  
HCMC is the central laboratories that will be used in this study to measure blood parameters 
University of Washington is the laboratory that will be used for NAD, GHS/GSSG and ATP/AMP 
analyses in this study.  
Urine pregnancy test will be performed at the Prism clinical site.  
 
Termination of the Trial 
In the case of premature termination of the trial, participating investigators/participants, and the 
Institutional Review Board must be promptly informed of the termination. 

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Protocol Amendments 
If amendments to the study protocol are required after approval such changes will be captured in writing 
the reasons for the change documented and signed and dated by the sponsor.  Any such amendments may 
be subject to IRB review/approval prior to implementation. Exception: if it becomes necessary to alter the 
protocol to eliminate an immediate hazard to participants, an amendment may be implemented prior to 
IRB approval.  In this circumstance, the Investigator must notify IRB in writing within five (5) working 
days of the implementation. 
 
 

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10 SAFETY INSTRUCTIONS AND GUIDANCE  
 
Adverse Events and Laboratory Abnormalities 
10.1.1 Adverse Events 
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant who has 
been administered an investigational product and does not necessarily have a causal relationship with this 
treatment.  An AE can be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of a product, whether or not it is 
considered related to that product.  Pre-existing conditions that worsen during a study are to be reported 
as AEs. 
During the study, participants should record any adverse effects in their diary.  At each visit the 
participant will be asked, "Have you experienced any difficulties or problems since I saw you last?".  Any 
adverse events (AEs) will be documented in the study record and will be classified according to the 
description, duration, intensity, frequency, and outcome.  The qualified investigator will assess any AEs 
and decide causality. 
Intensity of AEs will be graded on a three-point scale (mild, moderate, severe) and reported in detail in 
the study record. 
Mild:  
Awareness of event but easily tolerated 
Moderate:          Discomfort enough to cause some interference with usual activity 
Severe:  
Inability to carry out usual activity 
The causality relationship of investigational product to the adverse event will be assessed by the qualified 
investigator as either: 
Most probable: There is a reasonable relationship between the investigational product and AEs. 
The event responds to withdrawal of investigational product (dechallenge) and 
recurs with rechallenge when clinically feasible. 
Probable: 
There is a reasonable relationship between the investigational product and AEs.  
The event responds to dechallenge. 
Possible: 
There is a reasonable relationship between the investigational product and AEs.  
Dechallenge information is lacking or unclear. 
Unlikely: 
There is a temporal relationship to the investigational product administration but 
there is no reasonable causal relationship between the investigational product and 
the AEs. 
Not related: 
There is no temporal relationship to investigational product administration or 
there is a reasonable causal relationship between non-investigational product, 
concurrent disease or circumstance and the AEs. 
 

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10.1.2 Serious Adverse Event 
A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side 
effect or precaution.  It is any AE that results in any of the following outcomes: 
1. Death 
2. A life-threatening adverse event 
3. Inpatient hospitalization or prolongation of existing hospitalization 
4. A persistent or significant disability or incapacity 
5. A congenital anomaly/birth defect in the offspring of a participant who received the study 
treatment 
Important medical events that may not be immediately life-threatening or result in death or hospitalization 
but may jeopardize the participant or may require intervention to prevent one of the outcomes listed 
above.  Examples of such events are intensive treatment in an emergency room or at home for allergic 
bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or the development 
of drug dependency or drug abuse. 
 
10.1.3 Unexpected Adverse Reaction 
An unexpected adverse reaction is an adverse reaction, the nature and severity of which is not consistent 
with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational 
product or package insert/summary of product characteristics for an approved product). 
 
10.1.4 Laboratory Test Abnormalities 
The investigator must assess the clinical significance of all abnormal laboratory values as defined by the 
compendium of normal values for the reference laboratory.  
Any treatment emergent abnormal laboratory result which is clinically significant, i.e., meeting one or 
more of the following conditions, should be recorded as a single diagnosis on the AEs form in the study 
record: 
1. Accompanied by clinical symptoms 
2. Leading to interruption or discontinuation of the investigational product 
3. Requiring a change in concomitant therapy 
This applies to any protocol and non-protocol specified laboratory result from tests performed after the 
first dose of the investigational product, which falls outside the laboratory reference range and meets the 
clinical significance criteria for liver and kidney tests as well as for hematology and clinical chemistry, 
etc. (i.e. AST and/or ALT > 2 x ULN). 
This does not apply to any abnormal laboratory result which falls outside the laboratory reference range 
but which does not meet the clinical significance criteria or those which are a result of an AE which has 
already been reported. 
Any laboratory result abnormality fulfilling the criteria for a serious adverse event (SAE) should be 
reported as such, in addition to being reported as an AE in the study record. 

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Treatment and Follow-Up Of AEs And Laboratory Abnormalities 
10.2.1 Treatment and Follow-up of AEs 
AEs, especially those for which the relationship to the investigational product is suspected, should be 
followed up until they have returned to baseline status or stabilized. 
If after follow-up, return to baseline status or stabilization cannot be established, an explanation should be 
recorded in the study record. 
 
10.2.2 Treatment and Follow-up of Laboratory Abnormalities 
In the event of participant-initiated withdrawal or clinically significant unexplained abnormal laboratory 
test values, the participant will be withdrawn from the treatment and will remain in the study and be 
required to attend all remaining study visits as part of a safety arm.  
 
 
Reporting of SAEs And Unexpected Adverse Reactions 
The qualified investigator will be responsible for classification of an AE as an SAE within 24 hours of 
notification. Causality should be signed off by the qualified investigator prior to reporting to ethics and 
regulatory bodies.  Notification of any serious adverse events must be made in writing to the study 
sponsor. The IRB will be notified of all product related SAEs and unexpected adverse reactions.   
 
 

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11 STATISTICAL EVALUATION 
 
 
Determination of Sample Size 
The planned total sample size will be 18 with 9 participants randomized to each treatment schedule. This 
sample size will enable detection of a difference of 8.7 pMol/mg protein in NAD+ concentration between 
the two treatments at an overall 5% significance level and 80% power. This sample size takes into 
account a loss to follow up rate of 20%. 
This calculation is based on a critical difference in NAD+ concentration, between NR and placebo of 6.1 
pMol/mg protein and a standard deviation of 11.04 units reported in a study by Martens et al. (2018)(13). 
 
 
Analysis Plan 
The Safety Population will consist of all participants who received any amount of either product, 
and on whom any post-randomization safety information is available. 
The Intent-to-Treat (ITT) Population consists of all participants who received either product 
and on whom any post-randomization efficacy information is available. 
The Per Protocol (PP) Population consists of all participants who consumed at least 80% of 
treatment or placebo doses, do not have any major protocol violations and complete all study 
visits and procedures connected with measurement of the primary variable. 
 
Statistical Analysis Plan 
The primary outcome is the change in whole blood NAD+ levels from baseline to day 6 compared between 
RiaGev™ and comparator. 
An effectiveness analysis based on the intent-to-treat population and an efficacy analysis based on the per 
protocol population will be performed. Safety analysis will be done for the safety population.  
Variables will be tested for normality and transformed to the log scale if found to be non-normally 
distributed. Log-normally distributed variables will be analyzed in the logarithmic domain. Intractably non-
normal outcome variables will be analyzed by appropriate non-parametric tests. 
Missing values in the intent-to-treat and per protocol analyses will be imputed using the most recent 
previously-available value (LOCF, or “last-observation-carried-forward” imputation) or multiple 
imputation methods. No imputation will be performed for missing safety values. 
For each continuous endpoint, a summary table will be prepared with a variety of summary statistics 
including mean, standard deviation, median and range values for each time point-treatment pairing. To 
account for any a priori differences between groups, the summary statistics of the changes from baseline 
will also be provided. For parameters requiring a logarithmic transformation, the summary statistics will be 
provided as non-transformed values. Mean values will be displayed as graphs, with a separate line for each 
product, and error bars indicating standard errors or standard deviations. Mean changes from baseline will 
be graphed similarly. Although imputed data will be used for significance testing, non-imputed data will be 
used for presenting summaries. Categorical variables will be summarized as counts and percentages. 

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Continuous efficacy endpoints will be tested for significance between groups by Analysis of Covariance 
(ANCOVA). The dependent variable will be the measurement at each visit, the factor will be the treatment 
group, and the value at baseline (Day 1) will be the covariate. A within group analysis on 
effectiveness/efficacy endpoints will be done using the Student’s paired t-test or, in the case of intractable 
non-normality, the Wilcoxon sign rank test. Categorical variables will be compared using Chi-squared or 
Fisher’s Exact tests as appropriate. 
Probabilities < 0.05 will be considered statistically significant. All statistical analysis will be completed 
using the R Statistical Software Package Version 3.5.2 (R Core Team, 2018) for Microsoft Windows. 
11.3.1 Premature Discontinuation Description 
For each premature discontinuation, the following parameters will be listed: participant number, dates of 
start and end of treatment, and the reason of premature discontinuation. 
11.3.2 Safety 
For adverse events, a descriptive analysis will be given.  Adverse events will be presented in a frequency 
table by category and treatment.  Furthermore, description, frequency, severity and causality will be 
reported for each adverse event. 
Continuous safety parameters (e.g. hematology, clinical chemistry, heart rate and blood pressure) will be 
summarized using a table including mean, standard deviation, median, minimum value, and maximum 
value for each measurement point. The changes from baseline will also be summarized similarly. 
 
 
Protocol Deviation Description 
Protocol deviations will be listed in the final study report. 
 
 
Protocol Amendments 
Once the protocol has been approved by the IRB, any changes to the protocol must be documented in the 
form of an amendment. All amendments will be documented in the final study report. 
 
12 DATA COLLECTION AND STORAGE 
All data collection and record storage will be done in compliance with ICH GCP Guidelines and 
applicable local regulatory guidelines. Existing, modified, and newly developed eCRFs (electronic case 
report forms) and clearly defined instructions for their correct use will be used to gather the study data. 
Quality assurance will be conducted on the database prior to collecting the data (anticipating problems 
with data collection), and quality control activities (such as recognition, monitoring and troubleshooting) 
will be conducted during and after the data is collected to ensure the integrity and validity of study results. 
The data will be handled and stored in OpenClinica Enterprise Version 4 (a cloud-based electronic case 
report form compliant with the industry regulations) and MS Access database.   
 
 

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13 ETHICAL ASPECTS OF THE STUDY 
This study will be conducted with the highest respect for the individual participants (i.e., participants) 
according to the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and 
the ICH Harmonised Tripartite Guideline for GCP.  
 
 
IRB Approval 
Prism Clinical Research and KGK Science Inc. will supply relevant documents for submission to an IRB 
for the protocol’s review and approval. The following must be submitted to the IRB: this protocol, a copy 
of the informed consent form, and, if applicable, volunteer recruitment materials and/or advertisements 
and other documents required by all applicable laws and regulations. The IRB’s written approval of the 
protocol and volunteer informed consent must be obtained before commencement of the study.  The IRB 
approval must refer to the study by exact protocol title, number, and version date; identify versions of 
other documents (e.g., informed consent form) reviewed; and state the approval date. 
Prism Clinical Research and KGK must adhere to all requirements stipulated by the IRB. This may 
include notification to the IRB regarding protocol amendments, updates to the informed consent form, 
recruitment materials intended for viewing by volunteers, local safety reporting requirements and 
submission of the investigator’s annual/final status report to the IRB. 
 
 
Volunteer Information and Informed Consent 
Written consent documents will embody the elements of informed consent as described in the declaration 
of Helsinki and the ICH Guidelines for GCP and will be in accordance with all applicable laws and 
regulations. The informed consent form describes the planned and permitted uses, transfers, and 
disclosures of the volunteer’s personal and personal health information for purposes of conducting the 
study. The informed consent form further explains the nature of the study, its objectives, and potential 
risks and benefits, as well as the date informed consent is obtained. The informed consent form will detail 
the requirements of the volunteer and the fact that he or she is free to withdraw at any time without giving 
a reason and without prejudice to his or her further medical care.  
 
 
Potential Risks and Procedures to Minimize Risk 
All potential risks are disclosed to study participants prior to their participation.  The potential risks 
associated with this study include venipuncture and the associated risks.  Risks associated with 
venipuncture include pain, bruising, and infection at the site.  Alcohol swabs and proper venipuncture 
procedure will be followed to minimize the risk of infection. 
 
 
 

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14 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Auditing 
All material used in clinical studies are subjected to quality control. Quality assurance audits may be 
performed by the sponsor or any health authority during the course of the study or after its completion.  
The Investigator agrees to comply with the sponsor and regulatory requirements in terms of auditing of 
the study. This includes access to the source documents for source data verification. 
 
 
Monitoring 
An initiation meeting will be conducted by the sponsor or an approved representative (CRO).  At this 
meeting, the protocol and logistical aspects of the study will be reviewed with the Investigator and all 
study staff. 
Source documents will be reviewed to ensure that all items have been completed and that the data 
provided are accurate and obtained in the manner specified in the protocol.  The participant files will be 
reviewed to confirm that: 
1. Informed consent was obtained and documented 
2. Enrolled participants fulfilled all inclusion criteria and did not meet any exclusion 
criteria; 
3. AE/SAE reporting has been performed as applicable 
4. Study visits have been conducted as per protocol and information has been recorded in 
the appropriate place in the source document 
5. The study product is being stored correctly and an accurate record of its dispensation to 
the study participants is being maintained (accountability) 
Incorrect, inappropriate, or illegible entries in the participant files will be returned to the Investigator or 
designee for correction.  No data disclosing the identity of participants will leave the study center. The 
Investigator and any designees will maintain confidentiality of all participant records. 
The Investigator will permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspections 
and will allow direct access to source data and documents for these purposes. 
 
 
Data Management 
Data required for the analysis will be acquired from source documentation (including laboratory reports) 
and entered into OpenClinica Enterprise Version 4 (OC4) study instance designed specifically for this 
study. The database design starts by revising the finalized study protocol and source documents. eCRFs 
(electronic case report form) will be created and coded as per study protocol and source documents. The 
two environments for the database will be created: test instance and production instance. A UAT (User 
Acceptance Testing) of the database will be performed in the test environment. The database will be 
reviewed thoroughly to ensure that all datapoints have been completed and that the data collected is accurate 
and obtained as specified in the study protocol. After conducting this quality control on content, 
functionality and validation checks, the database will be approved be moved to the production environment. 
A password protected user ID’s will be created which will give access to the limited and trained authorized 

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personnel. Only properly trained Data management staff will be granted access to perform database 
designing, according to SOP PC 115 GCP - Designing Database in OpenClinica Enterprise Version and 
SOP PC 114 GCP - Creating user in OpenClinica Enterprise Version. A study specific Data Management 
Plan will be generated after the finalization of the database.   
The standard data validation and edit checks will be performed on the production environment of the study 
by designing study specific validation checks and restrictions as per study protocol.  Automatic and 
manually generated discrepancies will be queried and managed according to the SOP PC 116 GCP - 
Discrepancy Management SOP in OpenClinica Enterprise Version 4. Data will be extracted and tables will 
be created, queried and exported during and at the end of study using PostgreSQL tool (pgadminIII 9.5) 
and MS Access.  
For Statistical analysis, the validated soft lock copy of the blinded study database will be sent to the 
Statistician to perform the analysis. The study database will be a read-only file to ascertain changes in the 
data are not made during or after the analysis.  
High safety standards for the transfer and storage of study data are guaranteed by the use of technologies 
such as password protection, firewalls and periodic backup to protect stored data.  
All study data is archived for a period not less than 2 years from the date of completion of the study in 
accordance with ICH Harmonised Guideline for Good Clinical Practice. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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REFERENCE LIST 
1.  
Aman Y, Qiu Y, Tao J, Fang EF. Therapeutic potential of boosting NAD+ in aging and age-related 
diseases. Transl Med Aging. 2018 Jan;2:30–7.  
2.  
Mark Mather, Linda A. Jacobsen, Kelvin M. Pollard. Aging Baby Boomers to Face Caregiving, 
Obesity, Inequality Challenges [Internet]. population reference bureau; 2016 Jan. Available from: 
https://www.prb.org/unitedstates-population-bulletin/ 
3.  
Diabetes [Internet]. world health organization; 2018 Oct. Available from: 
https://www.who.int/news-room/fact-sheets/detail/diabetes 
4.  
RiaGev® [Internet]. bioenergy life science Inc.; Available from: 
http://bioenergylifescience.com/#products 
5.  
Compound Summary for CID 10975657 D-Ribose [Internet]. National Center for Biotechnology 
Information; [cited 2019 Feb 28]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/D-
ribopyranose#section=Food-Additives-and-Ingredients 
6.  
Mahoney DE, Hiebert JB, Thimmesch A, Pierce JT, Vacek JL, Clancy RL, et al. Understanding D-
Ribose and Mitochondrial Function. Adv Biosci Clin Med. 2018 Feb 13;6(1):1.  
7.  
Niacin Fact Sheet for Health Professionals [Internet]. National Institutes of Health; 2019. Available 
from: https://ods.od.nih.gov/factsheets/Niacin-HealthProfessional/#h9 
8.  
Meyer-Ficca M, Kirkland JB. Niacin. Adv Nutr. 2016 May 1;7(3):556–8.  
9.  
Will PM, Walter JD. Exercise testing: Improving performance with a ramped Bruce protocol. Am 
Heart J. 1999 Dec;138(6):1033–7.  
10.  Milani RV, Lavie CJ, Mehra MR, Ventura HO. Understanding the Basics of Cardiopulmonary 
Exercise Testing. Mayo Clin Proc. 2006 Dec;81(12):1603–11.  
11.  Dickman JR, Koenig RT, Ji LL. American Ginseng Supplementation Induces an Oxidative Stress in 
Postmenopausal Women. 2009;28(2):219–28.  
12.  Bugaj O, Zieliński J, Kusy K, Kantanista A, Wieliński D, Guzik P. The Effect of Exercise on the 
Skin Content of the Reduced Form of NAD and Its Response to Transient Ischemia and Reperfusion 
in Highly Trained Athletes. Front Physiol. 2019 May 15;10:600.  
13.  Martens CR, Denman BA, Mazzo MR, Armstrong ML, Reisdorph N, McQueen MB, et al. Chronic 
nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged 
and older adults. Nat Commun [Internet]. 2018 Dec [cited 2018 Dec 3];9(1). Available from: 
http://www.nature.com/articles/s41467-018-03421-7 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 46 of 52 
 
 
15 APPENDICES 
 
Appendix I: Schedule of Assessments 
Period 1 
 
 
 
Period 2 
 
Procedures/assessments 
Visit 
1 
Scree
n  
Visit 2 
Day 1 
(+1 
Day) 
Visit 3 
Day 3 
(+1 
Day) 
Visit 4 
Day 5 
(+1 
Day) 
Visit 5 
Day 8 
(+1 Day) 
 
 
Visit 6 
Day 1 
(+1 
Day) 
Visit 7 
Day 3 
(+1 
Day) 
Visit 8 
Day 5 
(+1 
Day) 
Visit 9 
Day 8 
(+1 
Day) 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
Review inclusion/exclusion 
criteria 
X 
X 
 
 
 
 
 
 
 
 
Review medical history 
X 
 
 
 
 
 
 
 
 
 
Review concomitant 
therapies 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
Vitals: Height*, weight, heart 
rate, blood pressure 
*Height will only be 
measured at Visit 1 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
Urine pregnancy test 
X 
X 
 
 
 
 
 
 
 
 
Electrocardiogram (EKG) 
x 
 
 
 
 
 
 
 
 
 
Physical examination 
X 
X 
 
 
 
 
 
 
 
X 
Randomization 
 
X 
 
 
 
 
 
 
 
 
CBC, electrolytes (Na, K, Cl), 
HbA1c*, fasting glucose, 
eGFR, creatinine, AST, ALT, 
and total bilirubin 
*HbA1c will only be 
measured at Visit 1 
X 
 
 
 
X 
 
X 
 
 
X 
Maximum heart rate (HRmax) 
treadmill test  
X 
 
 
 
 
 
 
 
 
 
Skin fluoroscopy for NADH 
analysis (optional) 
 
X 
 
 
X 
 
X 
 
 
X 
Blood Collection for NAD+ 
analysis 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
Blood Collection for 
GSH/GSSG and ATP/AMP 
analyses  
 
X 
 
 
X 
 
X 
 
 
X 
OGTT: glucose and insulin T= 
0, 15m, 30m, 45m, 60m, 
90m, 2h 
 
X 
 
 
X 
 
X 
 
 
X 
Questionnaire 
 
X 
X 
X 
X 
 
X 
X 
X 
X 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 47 of 52 
 
 
Procedures/assessments 
Visit 
1 
Scree
n 
 
Visit 2 
Day 1 
(+1 
Day) 
Visit 3 
Day 3 
(+1 
Day) 
Visit 4 
Day 5 
(+1 
Day) 
Visit 5 
Day 8 
(+1 Day) 
 
 
Visit 6 
Day 1 
(+1 
Day) 
Visit 7 
Day 3 
(+1 
Day) 
Visit 8 
Day 5 
(+1 
Day) 
Visit 9 
Day 8 
(+1 
Day) 
Treadmill Exercise protocol  
 
X 
 
 
X 
 
X 
 
 
X 
Salivary Collection Kit 
Dispensed 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
Salivary Collection Kit 
Returned  
 
X 
X 
X 
X 
 
X 
X 
X 
X 
Food Records Dispensed 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
Food Records Collected 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
IP Dispensed 
 
X 
X 
X 
 
 
X 
X 
X 
 
IP Returned  
 
 
X 
X 
X 
 
 
X 
X 
X 
Subject Diary Dispensed 
X 
X 
X 
X 
X 
 
X 
X 
X 
 
Subject Diary Returned 
 
X 
X 
X 
X 
 
X 
X 
X 
X 
Standardized Meal 
 
X 
 
 
X 
 
X 
 
 
X 
Compliance Calculated 
 
 
X 
X 
X 
 
 
X 
X 
X 
Adverse Events  
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
 
 
 
 
 
7-day washout  
(+3 days) 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 48 of 52 
 
 
Standardized Meal Items  
A menu for the standardized meal will be provided to the participants at visits 2, 5, 6 and 9. Participants 
should be encouraged to consume the entire meal. All food that is not eaten is to be weighed and 
recorded. Participants will then be provided with an equivalent meal at their next visit. 
Standardized Food Menu 
BREAKFAST (standardized, before blood collection at t=2 h) 
¼ cup blueberries 
1 medium banana  
¾ cup plain Greek yogurt 
½ tbsp honey 
¼ cup granola 
1 slice whole grain toast 
1 tbsp almond butter 
1 x Babybel original cheese portion 
250 ml decaffeinated coffee 
\water, ad libitum water will be provided 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 49 of 52 
 
 
Dietary Guideline  
Participant Initials: __________                                                Participant Number: __________ 
 
Dietary Guidelines  
 
Please use the following guidelines to help you make meal and snack choices between study visits that are 
appropriate for the study.   
Foods to Avoid: 
• Energy drinks, Vitamin Water, and sports drinks 
• Yeast spread (vegemite, marmite, etc.) 
• French bread 
• Condensed tomato soup and related products 
• Ready-to-eat cereals 
• Game meat 
• Turkey 
 
Foods to Limit (No more than 1 serving per day): 
• Dairy products (milk, cheese, yogurt) 
• Beans/legumes/lentils 
• Soybeans/soy products 
• Poultry (chicken, duck etc.) 
• Red meat (beef, veal, lamb, pork) 
• Organ meats 
• Fish, shellfish and crustaceans 
• All commercial and homemade beers, and homemade wines 
 
Suggested Breakfast Options  
• 
Fried eggs with white toast and breakfast potatoes/hash browns 
• 
Fruit salad 
• 
Yogurt with fruit (no granola) 
 
Suggested Lunch Options  
• 
Quinoa salad with bell peppers and corn  
• 
Oven-baked chicken strips with roasted potatoes  
• 
Garden salad with grilled chicken or hard-boiled egg 
 
Suggested Dinner Options   
• 
Vegetable stir fry with steamed rice  
• 
Beef, chicken, or vegetable tacos with corn tortillas (not flour) 
• 
Baked chicken or pork with broccoli and potatoes 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 50 of 52 
 
Suggested Snack Options   
• 
Apple with nut butter 
• 
Fruit salad  
• 
Celery and carrot sticks with dressing 
 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 51 of 52 
 
 
Maximum Heart Rate Treadmill Test Protocol (9)  
 
 
 

Protocol 19RNHB: 
A randomized, double-blind, comparator-controlled, cross-over study to 
investigate the safety and efficacy of RiaGev™ in healthy adults 
 
October 4th, 2019 
 
 
-Confidential- 
Page 52 of 52 
 
 
Checklist Individual Strength Questionnaire