Randomized, Single-blinded, Controlled, Parallel-arm Study to Evaluate the Effect of Fast Bar(TM) on Physiological Fasting Condition
Phase: NA
Conditions: Fasting
Sponsor: L-Nutra Inc

Fast Bar 
Version 1.0 
Protocol [XXXXXX] 
 
June 19, 2020 
 
Official Title:   
Randomized, Single-blinded, Controlled, Parallel-arm 
Study to Evaluate the Effect of Fast BarTM on 
Physiological Fasting Condition 
Short Title:  
 
“Fast Bar” 
Protocol Number:   
[XXXXXX] 
Principal Investigator(s): William C. Hsu, MD 
Sponsor:  
 
L-Nutra, Inc. 
Funded by:  
 
L-Nutra, Inc. 
Version Number:    
v.1.0 
Date:  
 
June 19, 2020 
 
 

  
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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
1 
PROTOCOL SUMMARY ............................................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................................ 1 
1.2 
Schema ................................................................................................................................................. 2 
1.3 
Schedule of Activities (SoA) ............................................................................................................... 3 
2 
INTRODUCTION ............................................................................................................................................ 3 
2.1 
Study Rationale .................................................................................................................................... 3 
2.2 
Background........................................................................................................................................... 4 
2.3 
Risk/Benefit Assessment .................................................................................................................... 4 
2.3.1 
Known Potential Risks ..................................................................................................... 4 
2.3.2 
Known Potential Benefits ................................................................................................ 5 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 5 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 5 
4 
STUDY DESIGN ............................................................................................................................................. 5 
4.1 
Overall Design ...................................................................................................................................... 5 
4.2 
Scientific Rationale for Study Design................................................................................................ 6 
4.3 
Justification for Dose ........................................................................................................................... 6 
4.4 
End of Study Definition ....................................................................................................................... 6 
5 
STUDY POPULATION .................................................................................................................................. 6 
5.1 
Inclusion Criteria .................................................................................................................................. 6 
5.2 
Exclusion Criteria ................................................................................................................................. 7 
5.3 
Lifestyle Considerations ...................................................................................................................... 7 
5.4 
Screen Failures .................................................................................................................................... 7 
5.5 
Strategies for Recruitment and Retention ........................................................................................ 7 
6 
STUDY INTERVENTION .............................................................................................................................. 8 
6.1 
Study Intervention(s) Administration ................................................................................................. 8 
6.1.1 
Study Intervention Description ....................................................................................... 8 
6.1.2 
Dosing and Administration .............................................................................................. 8 
6.2 
Preparation/Handling/Storage/Accountability .................................................................................. 8 
6.2.1 
Acquisition and accountability ........................................................................................ 8 
6.2.2 
Formulation, Appearance, Packaging, and Labeling .................................................. 8 
6.2.3 
Product Storage and Stability ......................................................................................... 9 
6.2.4 
Preparation ........................................................................................................................ 9 
6.3 
Measures to Minimize Bias: Randomization and Blinding ............................................................. 9 
6.4 
Study Intervention Compliance .......................................................................................................... 9 
6.5 
Concomitant Therapy .......................................................................................................................... 9 
6.5.1 
Rescue Medicine .............................................................................................................. 9 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................... 10 
7.1 
Discontinuation of Study Intervention ............................................................................................. 10 
7.2 
Participant Discontinuation/Withdrawal from the Study ............................................................... 10 
7.3 
Lost to Follow-Up ............................................................................................................................... 10 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 10 
8.1 
Efficacy Assessments ....................................................................................................................... 10 
8.2 
Safety and Other Assessments ....................................................................................................... 11 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 11 

  
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8.3.1 
Definition of Adverse Events (AE) ............................................................................... 11 
8.3.2 
Definition of Serious Adverse Events (SAE) .............................................................. 11 
8.3.3 
Classification of an Adverse Event .............................................................................. 11 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 12 
8.3.5 
Adverse Event Reporting .............................................................................................. 12 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 12 
8.3.7 
Reporting Events to Participants ................................................................................. 12 
8.3.8 
Events of Special Interest ............................................................................................. 12 
8.3.9 
Reporting of Pregnancy ................................................................................................ 12 
8.4 
Unanticipated Problems ....................................................................... Error! Bookmark not defined. 
8.4.1 
Definition of Unanticipated Problems (UP) ................................................................. 13 
8.4.2 
Unanticipated Problem Reporting ................................................................................ 13 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 13 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 13 
9.1 
Statistical Hypotheses ....................................................................................................................... 13 
9.2 
Sample Size Determination .............................................................................................................. 13 
9.3 
Populations for Analyses .................................................................................................................. 13 
9.4 
Statistical Analyses............................................................................................................................ 15 
9.4.1 
General Approach .......................................................................................................... 15 
9.4.2 
Analysis of the Primary Efficacy Endpoint(s) ............................................................. 15 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 15 
9.4.4 
Safety Analyses .............................................................................................................. 15 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 15 
9.4.6 
Planned Interim Analyses ............................................................................................. 15 
9.4.7 
Sub-Group Analyses ..................................................................................................... 15 
9.4.8 
Tabulation of Individual participant Data .................................................................... 15 
9.4.9 
Exploratory Analyses ..................................................................................................... 16 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 16 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 16 
10.1.1 
Informed Consent Process ........................................................................................... 16 
10.1.2 
Study Discontinuation and Closure ............................................................................. 16 
10.1.3 
Confidentiality and Privacy ........................................................................................... 17 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 17 
10.1.5 
Key Roles and Study Governance .............................................................................. 17 
10.1.6 
Safety Oversight ............................................................................................................. 17 
10.1.7 
Clinical Monitoring .......................................................................................................... 18 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 18 
10.1.9 
Data Handling and Record Keeping ............................................................................ 18 
10.1.10 
Protocol Deviations ........................................................................................................ 18 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 19 
10.1.12 
Conflict of Interest Policy .............................................................................................. 19 
10.2 
Additional Considerations ................................................................................................................. 19 
10.3 
Abbreviations ...................................................................................................................................... 20 
10.4 
Protocol Amendment History ........................................................................................................... 20 
11 
REFERENCES ............................................................................................................................................. 21 
 

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STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Conference on Harmonization Good Clinical 
Practice (ICH GCP) and the following:  
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 
CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812)  
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both the 
protocol and the consent form will be obtained before any participant is enrolled.  Any amendment to 
the protocol will obtain review and approval by the IRB before the changes are implemented to the 
study.  In addition, all changes to the consent form will be IRB-approved; a determination will be made 
regarding whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Randomized, Single-blinded, Controlled, Parallel-arm Study to Evaluate the 
Effect of Fast BarTM on Physiological Fasting Condition 
Study Description: 
This study evaluates how Fast BarTM, a specially formulated energy bar, 
affects the physiological condition in participants after an overnight 
fasting.   
Participants will fast for 19 hours (Fast Group), consume a breakfast Bar 
(Breakfast Group) or a Fast BarTM (Fast Bar Group) after an approximately 
15-hour overnight fasting.   
Participants will be assessed for physiological parameters associated with 
fasting.   
Objectives: 
 
Primary Objective: 
The objective of this study is to evaluate the metabolic effects of 
consuming a novel food product (Fast Bar™), as compared to consuming a 
bar that resembles a typical breakfast, after an overnight fasting.  
Secondary Objectives:  
To assess the effect of a Fast BarTM on facilitating fasting by modulating 
subjective variables.   
Endpoints: 
Primary Endpoint:   
Physiological condition associated with fasting: 
• 
Blood ketone (BHB) level 
• 
Blood glucose level 
Secondary Endpoint:  
Questionnaires:  
• 
Food diary 
• 
Food evaluation 
• 
Self-evaluation 
 
Study Population: 
A total of 108, adult male and female, generally healthy subjects. 
Phase: 
N/A   

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Description of 
Sites/Facilities Enrolling 
Participants: 
Participants will be recruited via email or telephone.  
Participants will be consented via Zoom tele-conference. 
The study will be carried out at participants’ home. 
Description of Study 
Intervention: 
 
Study subjects will consume a standardized ready-to-eat meal as dinner 
the day before testing and asked to fast for approximately 15 hours.  
Study subjects will either continue to fast for 6 hours (Fast Group), 
consume either a breakfast (Breakfast Group) or a Fast BarTM (Fast Bar 
Group). 
Study Duration: 
3 months 
Participant Duration: 
2 days 
1.2 
SCHEMA 
 
  
Screening
Participant signs 
IC & HIPAA
Participant 
eligible for 
study?
Day 1 Dinner 
before 5 pm
Day 2 Fast BarTM
after 8am
STOP
Indicate reason on 
Screening Log
Assign to 
Arms
No
Yes
Breakfast
Water Fast
Randomization
STOP
Day 1 Dinner 
before 5 pm
Day 2 Water-only 
fast till 12pm
STOP
Day 1 Dinner 
before 5 pm
Day 2 Breakfast
after 8am
STOP
Fast Bar

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1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
Screening  
Day 1  
Day 2 
 
Day 
 
1 
T0 
T1 
T2 
T3 
T4 
Hours 
 
 
Baseline 
+1 h 
+2 h 
+3 h 
+4 h 
Example clock times 
 
 
8 am 
9 am 
10 am 
11 am 
12 pm 
Procedures 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
Randomization 
X (1) 
 
 
 
 
 
 
Blood draw (Fingerstick) 
• 
ketone (BHB)  
• 
glucose 
 
X  
(morning, 
fasting) 
X 
X 
X 
X 
X 
Intervention 
 
Healthy Eating Style 
X (2) 
 
 
 
 
 
 
Dinner, followed by 15 h 
water-only fasting 
 
X (before  
5 pm) 
 
 
 
 
 
Breakfast Bar 
 
 
X (after  
T0 test) 
 
 
 
 
Fast BarTM 
 
 
X (after  
T0 test) 
 
 
 
 
Water-only fast 
 
 
X 
X 
X 
X 
X 
Questionnaires/ Surveys 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Contact Information 
X 
 
 
 
 
 
 
Medical history 
Concomitant  
medications 
X 
 
 
 
 
 
 
24-h dietary recall 
X 
 
 
 
 
 
 
Food diary 
 
X 
 
 
 
 
 
Self-evaluation  
 
 
X (after  
T0 test) 
 
 
X 
 
Food evaluation 
 
 
 
X 
 
 
 
(1) Subjects will be assigned to study arms according to the randomization scheme generated by using the 
web site Randomization.com (http://www.randomization.com). 
(2) Subjects will be provided with a USDA MyPlate Plan according to his/her BMI and physical activity  level 
(https://www.choosemyplate.gov/resources/MyPlatePlan) and encouraged to adopt the recommended 
healthy eating style for 2-3 days before starting the trial.  
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
The objective of this study is to evaluate the metabolic effects of consuming a novel food product (Fast 
Bar™) after overnight fasting. 
Interest in fasting-based programs (i.e. intermittent fasting) for improvement of health and longevity 
continues to grow [1-3]. While benefits of intermittent fasting have been convincingly demonstrated in 
rodent models, the more limited data in humans is less clear. As such, additional investigations of the 

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effects of fasting-based protocols in humans are needed. The short-term fasting (e.g. 12 to 48 hours in 
duration) utilized in many intermittent fasting programs are considered safe, but some individuals may 
find them subjectively difficult. As such, the question of whether the benefits of fasting can be obtained 
while small amounts of food are consumed is of substantial interest. An attractive strategy may be to 
consume small quantities of foods specifically formulated to maintain a fasted or pseudo-fasted state. If 
such a strategy is successful, the benefits of fasting may be maintained even though a small amount of 
food consumption, which will alleviate subjective feelings of hunger and promote adequate nutritional 
intake. 
One commercially available product that is designed to be consumed during periods of intermittent 
fasting is the Fast Bar™ (www.fastbar.com),which stems out of the well-researched fasting-mimicking 
diet [4, 5] to assist prolonged fasting. The unique formulation of the Fast Bar™, which consists of nuts and 
other select ingredients, is thought to minimize deviations in metabolic biomarkers associated with a 
fasting state. This may allow for extension of a fasting period through reduced subjective difficulty of 
fasting. However, these items have yet to be evaluated for its effects during intermittent fasting through 
a controlled research trial. As such, the objective of this study is to evaluate the metabolic and subjective 
effects of consuming a novel food product (Fast Bar™) after a short period of fasting. 
2.2 
BACKGROUND  
Negative energy balance induced by calorie restriction (CR) or increased energy expenditure induced by 
exercise (EX) improves all metabolic coronary heart disease (CHD) risk factors, including plasma LDL-
cholesterol, total cholesterol/HDL ratio, HOMA-IR index, and CRP concentrations [6, 7].  However, chronic 
calorie restriction, whose beneficial effects have been known for decades, has not been adopted by even 
a small percentage of the US population, in part because compliance to chronic and extreme diets is very 
low.   
In healthy human subjects, three monthly cycles of fasting-mimicking diet (FMD) lasting 5 days reduced 
body weight, trunk and total body fat, and blood pressure [5].  In the same study, a post hoc analysis 
demonstrated that body mass index, blood pressure, fasting glucose, triglycerides, total and low-density 
lipoprotein cholesterol, and C-reactive protein were more beneficially affected in those participants with 
the highest baseline levels for the same variables, suggesting that FMD may be particularly effective in 
participants with established metabolic syndrome.  Moreover, FMD cycles restore insulin secretion and 
glucose homeostasis in both type 2 and type 1 diabetes mouse models.  In mice, a 4-day fasting mimicking 
diet (FMD) induced a stepwise expression of Sox17 and Pdx-1, followed by Ngn3-driven generation of 
insulin-producing b cells, indicating that FMD promotes the reprogramming of pancreatic cells to restore 
insulin generation in islets from T1D patients and reverse both T1D and T2D phenotypes in rodent models 
[8]. 
The Fast BarTM is a designed to provide energy without interfering with the protective and metabolic 
effects of fasting.  The Fast BarTM diets consist of 100% ingredients, which are generally regarded as safe 
(GRAS).   
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
A 14-18 hours overnight fasting is a common practice. However, it is possible that some participants may 
experience fatigue, weakness, low blood sugar.  

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Fingerstick is a common practice for checking blood glucose. Participants could experience pain, 
discomfort, bruising or infection (a slight risk any time the skin is broken).  Fingerstick devices should never 
be used for more than one person. 
Although participants will be screened for food allergies, it is possible that an allergic reaction could occur 
upon ingestion of the study foods. 
2.3.2 KNOWN POTENTIAL BENEFITS  
Short term known potential benefits: 
N/A 
Long term known potential benefits: 
N/A 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
RISKS  
The study intervention (overnight fasting and study food consumption) and procedure (fingerstick) pose 
a minimal risk to the study subjects. 
BENEFITS 
Participants may not receive any direct benefit from taking part in this study.  
3 
OBJECTIVES AND ENDPOINTS 
The research questions to be addressed are: 
1. What are the metabolic effects of consuming a Fast Bar™, as compared to consuming a typical 
breakfast, after an overnight fast? 
2. Based on the observed metabolic effects, does consumption of a Fast Bar™ allow for maintenance 
of the fasting state? 
3. Does consumption of a Fast Bar™ facilitate fasting by modulating subjective variables?   
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
 
 
Physiological condition 
associated with fasting 
• 
Blood ketone (ß-
hydroxybutyrate, BHB) level 
• 
Blood glucose level 
When hepatic glycogen stores are 
exhausted (after 12-24 hours of 
total fasting), the liver produces 
ketones (ketogenesis: acetoacetate 
(AA) and BHB to provide an energy 
substrate for peripheral tissues. 
Secondary 
 
 
Questionnaires 
• 
Food evaluation 
• 
Self-evaluation 
The secondary objective is to 
assess the subjective variables 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
This is quantitative research with a randomized, single-blinded, controlled, parallel-ar design.   

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Total length of subject participation is 2 days.   
The study will be carried out off-site (at participants’ home).   
After the explanation of the study and informed consent signature, eligible participants will be 
randomized to three groups.  
1. Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 
5 pm on day 1.  
2. Breakfast Group: overnight fasting (approximately 15 hours), then consume a breakfast on day 
2; 
3. Fast Bar Group: overnight fasting (approximately 15 hours), then consume a Fast BarTM on day 2. 
4. Water-only fasting group: overnight fasting (approximately 19 hours); 
5. Subject all groups will be asked not to consume any food or calorie-containing drinks other than 
the study foods till 2 pm on day 2. 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
This research will allow for scientific evaluation of the application of the Fast Bar™ during intermittent 
fasting.  That is, this research will allow for quantification of the changes in metabolic biomarkers after 
consumption of a Fast Bar™, following a period of acute fasting, to determine whether deviations from 
the fasted state are smaller and more transient than when consuming a breakfast bar.  This comparison 
will facilitate a better understanding of whether the Fast Bar™ is a viable strategy for extending the 
benefits of intermittent fasting despite the consumption of food. 
4.3 
JUSTIFICATION FOR DOSE 
Fasting leads to the mobilization of hepatic glycogen stores.  When the glycogen stores are exhausted 
(after 12-24 hours of total fasting), the liver produces ketones (ketogenesis: acetoacetate (AA) and ß-
hydroxybutyrate (BHB) to provide an energy substrate for peripheral tissues.  Consumption of food, 
depending on the composition of the food, i.e., the absolute levels and ratios of carbohydrate, protein 
and fat, may markedly affect the ketogenesis state.  We hypothesis that the specially formulated Fast 
BarTM will not significantly impact the overnight fasting-induced ketogenesis state. 
4.4 
END OF STUDY DEFINITION 
The end of the study is defined as completion of the procedures shown in the Schedule of Activities 
(SoA) in the trial (Section 1.3). 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
An individual of any race and ethnicity who meets all of the following criteria will be included for 
participation in this study: 
• 
Ability and willingness to provide written informed consent; 
• 
Ability and willingness to use Zoom teleconference;  
• 
Ability and willingness to perform the study tests and adhere to study protocol (to the best of the 
participant's knowledge); 
• 
18-65 years of age (inclusive) at screening; 
• 
BMI  20-35 kg/m2 (inclusive) at screening; 

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• 
In good health (as determined by medical history to evaluate acute or ongoing chronic 
medical diagnoses/conditions that have been present for at least 90 days). 
 
5.2 
EXCLUSION CRITERIA 
An individual of any race and ethnicity who meets any of the following criteria will be excluded from 
participation in this study: 
• 
Has any medical disease or condition that, in the opinion of the principal investigator (PI) or 
appropriate study personnel, precludes study participation* (*Including acute, subacute, 
intermittent or chronic medical disease or condition that would place the subject at an 
unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, 
or may interfere with the evaluation of responses or the subject's successful completion of this 
trial); 
• 
History of gastric bypass (based on medical history provided at screening); 
• 
Under medications aimed at keeping blood glucose under control (based on medical history 
provided at screening); 
• 
Type 1 diabetes (based on medical history provided at screening); 
• 
Taking insulin, insulin analogs, or octreotide (based on medical history provided at screening); 
• 
Food allergies which would make the subject unable to consume the food provided (based on 
medical history and information provided at screening) (participants will be asked to review the 
ingredient lists for the dinner meal, the breakfast and the Fast BarTM, and to state that they are 
not allergic to the ingredients to the best of their knowledge); 
• 
Women who are pregnant; 
• 
Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks 
per day for men) (based on medical history and information provided at screening). 
5.3 
LIFESTYLE CONSIDERATIONS 
Participants will be asked to: 
• 
Finish the dinner (provided) by 5 pm on day 1, followed by an approximate 15-hour water-only 
fast;  
• 
Self-monitor blood glucose on day 1 (morning before breakfast) and on day 2; 
• 
Self-monitor blood ketone (BHB) on day 1 (morning before breakfast) and on day 2. 
5.4 
SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in the trial but are not subsequently 
randomly assigned to the study intervention or entered in the study.   
A minimal set of screen failure information including demography, screen failure details, eligibility criteria 
will be retained to ensure transparent reporting of screen failure participants, to meet the Consolidated 
Standards of Reporting Trials (CONSORT) publishing requirements and to respond to queries from 
regulatory authorities.   
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 

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Potential participants will be recruited via telephone and email.   
Participants will be enrolled via Zoom teleconference (https://www.zoom.com). 
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION DESCRIPTION 
Participants will be asked to consume a ready-to-eat dinner before 5 pm on day 1.  
Participants will be asked to refrain from consuming any food or drinks (except water) for 15 hours.  
On day 2, subjects will be asked  
• 
to continue the water-only fast for 4 more hours (Water Fast Group); 
• 
to consume a breakfast, and then continue to water-only fast for 4 more hours (Breakfast Group); 
• 
to consume a Fast BarTM, and then continue to water-only fast for 4 more hours (Fast Bar Group). 
6.1.2 DOSING AND ADMINISTRATION 
Participants will undergo 15 to 19 hours of water-only overnight fasting.   
Participants will consume a breakfast or a Fast BarTM.  
6.2 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
 
6.2.1 ACQUISITION AND ACCOUNTABILITY 
This study will use food products developed by the L-Nutra company.   
Study coordinator will be responsible to keep the inventory of products. 
Prepared study kits that includes all necessary study materials will be mailed to participants once they are 
enrolled and consented. 
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
L-Nutra company handles the formulation, appearance, packaging and labeling of all the food products 
for this study.   
The custom ready-to-eat dinner prior to fasting will be provided by Nutrition For Longevity, a subsidiary 
of L-Nutra. 
Dinner meal ingredients: Sockeye Salmon, Organic Red Cabbage, Organic Cooked White Rice, Organic 
Stir Fry Greens, Organic Broccoli, Organic Cauliflower Rice, Organic Carrots, Organic Onion, N4L 
Imported EVOO, N4L Teriyaki Sauce (Organic Pineapple Juice, Organic Japanese Rice Wine, Organic 
Ginger Root, Organic Tamari), Organic Garlic, Organic Scallions. 
Contains Fish, Soy, Tree Nuts. 
The breakfast bar is formulated to mimic a typical breakfast in energy contents. 

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Breakfast ingredients: Tapioca Syrup, Dates, Almond Butter, Almonds, Soy Protein Crisps (Soy Protein 
Isolate, Rice Flour, Malt Extract (may contain wheat), Micellar Casein, Whey Protein Concentrate, Pea 
Protein, Flaxseed, Almond Protein, Maltodextrin, Sunflower Lecithin, Sea Salt, Natural Flavor. 
Contains Milk, Soy and Almonds. May contain Wheat. 
Fast BarTM ingredients: Macadamia Nuts, Pecan Pieces, Inulin, Almond Meal, Almond Butter, Honey, 
Coconut Flour, Flaxseed Meal, Vanilla Powder, Sea Salt, Rosemary oleoresin. 
Product Contains: Tree nuts (almonds, coconut, macadamia nuts, pecans). Manufactured on equipment 
that also processes other tree nuts, peanuts, soy, wheat, egg, and milk. 
 
6.2.3 PRODUCT STORAGE AND STABILITY 
 
Food items need to be stored in a cool, dry place. 
 
6.2.4 PREPARATION 
 
N/A 
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
After screening, participants will be block randomized (12 blocks of 9 each) in a 1:1:1 allocation to the 
breakfast, Fast Bar and water-only fast groups using a predetermined randomization table.   
The following measures will be performed to minimize biases: 
• 
Subjects will be randomly assigned to either one of the two arms of the study; 
• 
Data and/or specimens will be labeled with a code that the research team can link to personal 
identifying information; 
• 
The study foods will be labelled with the participants’ code (by research personnel not directly 
interacting with the participants). 
  
6.4 
STUDY INTERVENTION COMPLIANCE 
Participants will be recruited via email and/or telephone. 
Potential participants will be provided with study-related documents over the email or mail.  
Potential participants will be consented over a Zoom conference with the study coordinator. A signed 
consent form will be emailed back to the PI using Docusign.  
Participants will be monitored via Zoom teleconference by the study personnel.   
6.5 
CONCOMITANT THERAPY 
N/A 
6.5.1 RESCUE MEDICINE 
N/A 

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STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
N/A 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a participant from the study for the following reasons: 
• 
Significant study intervention non-compliance; 
• 
If any clinical adverse event (AE), biomarker abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
participant; 
In case of discontinuation/withdrawal, the data collected up to the time of discontinuation from that 
specific participant will still be used as part of the trial database and statistical analysis of trial outcome. 
7.3 
LOST TO FOLLOW-UP 
N/A 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
EFFICACY ASSESSMENTS  
Participant outcomes will be reminded before starting fasting (day 1) and the end of fasting (day 2) via 
telephone calls, text message and/or email.  
Questionnaires will be self-administered through HIPAA compliant E-platform CRIO.  
Procedure List: 
• 
Screening (SCR): study explanation, informed consent, medical history, and instructions. 
• 
Day 1 
o finish dinner by 5 pm followed by water-only fasting; 
• 
Day 2 
o Continue the water-only fast, consume a breakfast or a Fast BarTM. 
 
Examination and tests will include: 
• 
Fingerstick for blood glucose and ketone (BHB) before breakfast on day 1; 
• 
Fingerstick for blood glucose and ketone (BHB) on baseline timepoint (before breakfast), and 1, 
2, 3, and 4 hours after consuming the breakfast bar or the Fast BarTM; 
• 
Questionnaires and Surveys:  
o Nurse’s Health Survey 2016 [9-11]: to evaluate medical history, newly developed 
conditions, changes in health conditions and healthcare utilization/medications; 
o Food evaluation; 
o Self-evaluation;  
 

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8.2 
SAFETY AND OTHER ASSESSMENTS 
N/A   
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)) 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions.  Important medical 
events that may not result in death, be life-threatening, or require hospitalization may be considered 
serious when, based upon appropriate medical judgment, they may jeopardize the participant and may 
require medical or surgical intervention to prevent one of the outcomes listed in this definition.  Examples 
of such medical events include allergic bronchospasm requiring intensive treatment in an emergency 
room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the 
development of drug dependency or drug abuse. 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines will 
be used to describe severity.   
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.   
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures.  Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment.  Severe events are usually incapacitating.  Of note, the term “severe” 
does not necessarily equate to “serious”. 
• 
Extreme – life-threatening or disabling 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All adverse events (AEs) must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the participant based on temporal relationship and his/her clinical judgment.  The 
degree of certainty about causality will be graded using the categories below.  In a clinical trial, the study 
product must always be suspect.   
• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event.  Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 

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• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 
8.3.3.3 EXPECTEDNESS  
William W Hsu, MD, will be responsible for determining whether an adverse event (AE) is expected or 
unexpected.  An AE will be considered unexpected if the nature, severity, or frequency of the event is not 
consistent with the risk information previously described for the study intervention.   
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study or upon review by a study personnel. 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate case report form (CRF).  Information to be collected includes event description, time of onset, 
clinician’s assessment of severity, relationship to study product (assessed only by those with the training 
and authority to make a diagnosis), and time of resolution/stabilization of the event.  All AEs occurring 
while on study must be documented appropriately regardless of relationship.  All AEs will be followed to 
adequate resolution. 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE.  However, if the study participant’s condition deteriorates at any time 
during the study, it will be recorded as an AE.   
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed.  AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
Angie Huang, MS, RDN, will record all reportable events with start dates occurring any time after informed 
consent is obtained until the last day of study participation.  Events will be followed for outcome 
information until resolution or stabilization. 
8.3.5 ADVERSE EVENT REPORTING  
Following adverse event (AE) or serious suspected adverse reaction will be reported to IRB within 10 
working days after investigators becoming aware of the event. 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
Following serious adverse event (SAE) or serious suspected adverse reaction will be reported to IRB within 
10 working days after investigators becoming aware of the event. 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
Angie Huang, MS, RDN, will report eventual AE and/or SAE to the participant.  Any adverse effects will be 
reported to participant directly in person or via phone/video conference/email. 
8.3.8 EVENTS OF SPECIAL INTEREST  
N/A  
8.3.9 REPORTING OF PREGNANCY  

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N/A 
8.3.10 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
participants or others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria: 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
8.3.11  UNANTICIPATED PROBLEM REPORTING  
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB).  The UP report will include the following information: 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP;  
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
8.3.12 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
 Angie Huang, MS, RDN, will report eventual UPs to the participant.  Any adverse effects will be reported 
to participant directly in person, via phone or Zoom. 
9 
STATISTICAL CONSIDERATIONS  
 
9.1 
STATISTICAL HYPOTHESES 
The primary trial outcome will be the ketone (beta-hydroxybutyrate, BHB) levels 3 hours (T3) after 
consuming the Fast and changes in BHB area under the curve (AUC) between 0 to 4 hours after consuming 
the study foods on day2. 
We hypothesize that the breakfast bar group will show significant lower blood BHB level compared to 
the Fast Bar group. 
9.2 
SAMPLE SIZE DETERMINATION 
Sample-size estimation is based on two considerations:  
1. Sample-size estimation is based on pilot studies assuming ketone (BHB) levels of 0.25 (SD: 0.19) 
and 0.16 (SD: 0.05) mM for the Fast Bar and the Breakfast groups, respectively.  With t test (one-

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tailed) of difference between two independent means, a total sample size of 62 will be necessary 
to achieve 80% power with an α error probability of 0.05. Sample size calculation was performed 
using the GPower v3.1.9.6 (Franz Faul, University Kiel, Germany; Actual power = 0.8164386; 
Actual α = 0.0291400).* 
2. Sample-size estimation is based on Fisher’s exact test (one tailed) for proportion difference 
between the breakfast and Fast Bar groups: food consumption will reduce blood ketone in 67% 
vs. 33% of the participants in the breakfast and Fast Bar groups, respectively. A total sample size 
of 64 will be necessary to achieve 80% power with an α error probability of 0.05.  ** 
 
Based on prior experience in similar dietary intervention studies, we anticipate an approximate 10% 
dropout and/or data loss.  36 subjects per group will be enrolled.  Sample size calculation was performed 
using the GPower v3.1.9.6 (Franz Faul, University Kiel, Germany; Actual power = 0.8164386; Actual α = 
0.0291400). A fasting only group (32 subjects) will also be included for comparison. A total 108 subjects 
will be enrolled. 
 
* t tests - Means: Difference between two independent means (two groups) 
Analysis: 
A priori: Compute required sample size  
Input: 
Tail(s) 
= One 
 
Effect size d 
= 0.6478342 
 
α err prob 
= 0.05 
 
Power (1-β err prob) 
= 0.8 
 
Allocation ratio N2/N1 
= 1 
Output: 
Noncentrality parameter δ 
= 2.5505258 
 
Critical t 
= 1.6706489 
 
Df 
= 60 
 
Sample size group 1 
= 31 
 
Sample size group 2 
= 31 
 
Total sample size 
= 62 
 
Actual power 
= 0.8096862 
 
** Exact - Proportions: Inequality, two independent groups (Fisher's exact test)  
Options: 
Exact distribution 
Analysis: 
A priori: Compute required sample size  
Input: 
Tail(s) 
= One 
 
Proportion p1 
= 0.67 
 
Proportion p2 
= 0.33 
 
α err prob 
= 0.05 
 
Power (1-β err prob) 
= 0.8 
 
Allocation ratio N2/N1 
= 1 
Output: 
Sample size group 1 
= 32 
 
Sample size group 2 
= 32 
 
Total sample size 
= 64 
 
Actual power 
= 0.8164386 
 
Actual α 
= 0.0291400 
 
9.3 
POPULATIONS FOR ANALYSES 

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All participants will be included in the intention-to-treat analyses of the results.  Participants who are 
removed from study for non-compliance or for safety reasons will still have their data included in the final 
analysis, unless they withdraw consent to have their data included, and will not be replaced.   
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
Continuous trial outcome variables will be evaluated for normality; normalizing transformations or 
nonparametric statistics will be used as needed.  All group comparisons on post-randomization efficacy 
outcomes will include randomized treatment (Fast Bar vs breakfast). A 1-sided level of significance set at 
P<0.05 will be used for the primary outcome; secondary and exploratory outcomes will not be adjusted 
for multiple hypothesis testing. 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
The primary trial outcome will be the ketone (beta-hydroxybutyrate, BHB) levels 3 hours (T3) after 
consuming the study foods (Breakfast Bar or Fast Bar) and changes in BHB area under the curve (AUC) 
between 0 to 4 hours after consuming the study foods on day2. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
The correlations of the time-dependent blood BHB levels between the groups (Fast Bar vs. Fasting and 
Fast Bar vs. Breakfast) will be carried out using Pearson correlation coefficient or Spearman's rank 
correlation analyses. 
Separate analyses by treatment groups will test for difference in mean levels of continuous or prevalence 
of categorical outcomes.   
9.4.4 SAFETY ANALYSES 
Incidences of adverse events and serious adverse events will be compared between treatment groups 
using Fisher’s exact tests.     
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
Baseline comparability between randomized groups will be evaluated for demographics, age, sex, BMI.  
Group differences will be evaluated with t-tests or nonparametric rank sum tests for continuous variables, 
and chi-square tests for categorical variables.  Standardized group differences (group difference divided 
by standard error of difference) will also be computed for each baseline variable. 
   
9.4.6 PLANNED INTERIM ANALYSES  
An interim analysis will be carried out when 50% of the trial has been completed. Interim analysis will 
assess the accrual rates, basic characteristics of the study population, protocol adherence, and answer 
following questions:  
1. Are the assumptions under which the original sample size was computed appropriate? 
2. Is it likely that a relevant intervention difference will be demonstrated? 
 
9.4.7 SUB-GROUP ANALYSES 
N/A 
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 

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N/A 
 
9.4.9 EXPLORATORY ANALYSES 
N/A 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
All institutional and Federal regulations concerning the Informed Consent form will be fulfilled.   
The study will be conducted in adherence to ICH Good Clinical Practice. 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting 
intervention/administering study intervention.  The following consent materials are submitted with this 
protocol: Informed Consent. 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Consent forms will be Institutional Review Board (IRB)-approved and the participant will be asked to read 
and review the document.  A verbal explanation will be provided in terms suited to the participant’s 
comprehension of the purposes, procedures, and potential risks of the study and of their rights as research 
participants.  Participants will have the opportunity to carefully review the written consent form and ask 
questions prior to signing.  The participants should have the opportunity to discuss the study with their 
family or surrogates or think about it prior to agreeing to participate.  The participant will sign the 
informed consent document prior to any procedures being done specifically for the study.  Participants 
will be informed that participation is voluntary and that they may withdraw from the study at any time, 
without prejudice.  A copy of the informed consent document will be given to the participants for their 
records.  The informed consent process will be conducted and documented in the source document 
(including the date), and the form signed, before the participant undergoes any study-specific procedures.   
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform 
study participants, the Institutional Review Board (IRB), and sponsor and will provide the reason(s) for the 
termination or suspension.  Study participants will be contacted, as applicable, and be informed of 
changes to study schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Safety: determination of unexpected, significant, or unacceptable risk to participants; 
• 
Study conduct: low accrual, poor retention. 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, and 
satisfy the sponsor and IRB. 

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10.1.3 CONFIDENTIALITY AND PRIVACY  
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
and the sponsor(s) and their interventions.  This confidentiality is extended to cover testing of biological 
samples and genetic tests in addition to the clinical information relating to participants.  Therefore, the 
study protocol, documentation, data, and all other information generated will be held in strict confidence.  
No information concerning the study, or the data will be released to any unauthorized third party without 
prior written approval of the sponsor.   
All research activities will be conducted in as private a setting as possible. 
The study participant’s contact information will be securely stored at Clinical Research IO (CRIO) E-
platform (https://www.clinicalresearch.io) for internal use during the study.  At the end of the study, all 
records will continue to be kept in a secure location for as long a period as dictated by the reviewing IRB. 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored at L-Nutra.  Individual participants and their research data will be identified 
by a unique study identification number.  The study data entry and study management systems will be 
secured and password protected.  At the end of the study, all study databases will be de-identified and 
archived at L-Nutra. 
• 
Research procedures will be conducted in participant’s home. 
• 
Data will be captured and reviewed in a private setting. 
• 
Only authorized research study personnel will be present during research related activities. 
• 
The collection of information about participants is limited to the amount necessary to achieve 
aims of the research. 
• 
Participants will not be approached in a setting or location that may constitute an invasion of 
privacy or could potentially stigmatize them 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
 
Data collected for this study will be analyzed and stored at L-Nutra.  After the study is completed, the de-
identified, archived data will be stored at L-Nutra for use by other researchers including those outside of 
the study.   
This study does not store biological specimens.   
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Name and contact information of the Principal Investigator and the Study Coordinator. 
Principal Investigator 
Co-Investigator/Study Coordinator 
William C. Hsu, MD 
Angie W. Huang, MS, RDN 
L-Nutra, Inc. 
L-Nutra, Inc. 
8000 Beverly Blvd, Los Angeles CA 90048 
8000 Beverly Blvd, Los Angeles CA 90048 
Tel: 617.655.4394 
Tel: 323.628.3158 
Email: whsu@l-nutra.com  
Email: awu@l-nutra.com  
 
10.1.6 SAFETY OVERSIGHT 
N/A  

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10.1.7 CLINICAL MONITORING 
The PI, William C Hsu, MD, to ensure that the rights and well-being of trial participants are protected, that 
the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in 
compliance with the currently approved protocol/amendment(s), with International Conference on 
Harmonization Good Clinical Practice (ICH GCP), and with applicable regulatory requirement(s). 
Angie W Huang, MS, RDN, will be overseeing the collected exams.  This include biochemical readout and 
subjective reporting by the subject of any change in diet use and compliance as well as 
adverse/unexpected symptoms and events. 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
Quality control (QC) procedures will be implemented beginning with the data entry system and data QC 
checks. 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is 
conducted and data are generated, documented (recorded), and reported in compliance with the 
protocol, International Conference on Harmonisation Good Clinical Practice (ICH GCP), and applicable 
regulatory requirements (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)).   
10.1.9 DATA HANDLING AND RECORD KEEPING  
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the trial staff at the site under the supervision of the Principle 
Investigator.  The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant enrolled in the study.  Data recorded in the electronic case report form 
(eCRF) derived from source documents should be consistent with the data recorded on the source 
documents.   
Clinical data (including adverse events (AEs), concomitant medications, and expected adverse reactions 
data) and clinical laboratory data will be entered into E-platform developed by Clinical Research IO (CRIO), 
a 21 CFR Part 11-compliant data capture system.  The data system includes password protection and 
internal quality checks, such as automatic range checks, to identify data that appear inconsistent, 
incomplete, or inaccurate.  Clinical data will be entered directly from the source documents. 
 
10.1.9.2 STUDY RECORDS RETENTION  
At the conclusion of the study, data will be retained for study record keeping purposes for at least 3 years.  
These documents will be retained for a longer period, however, if required by local regulations. 
10.1.10 
PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on 
Harmonisation Good Clinical Practice (ICH GCP).  The noncompliance may be either on the part of the 
participant, the investigator, or the study site staff.  As a result of deviations, corrective actions are to be 
developed by the site and implemented promptly.   
Protocol deviations will be sent to the reviewing Institutional Review Board (IRB) per their policies.  The 
site investigator is responsible for knowing and adhering to the reviewing IRB requirements. 

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10.1.11 
PUBLICATION AND DATA SHARING POLICY 
This trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to 
ClinicalTrials.gov.  In addition, every attempt will be made to publish results in peer-reviewed journals.   
 
10.1.12 
CONFLICT OF INTEREST POLICY 
L-Nutra, Inc.  received patent of the food used in this study from the University of Southern California and 
may develop products that can be sold.  If L-Nutra makes money from these products, participants will 
not receive any money. 
 
10.2 ADDITIONAL CONSIDERATIONS 
N/A 
 
 

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10.3 ABBREVIATIONS 
 
AE 
Adverse Event 
BHB 
ß-hydroxybutyrate 
CFR 
Code of Federal Regulations 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CRIO 
Clinical Research IO 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GMP 
Good Manufacturing Practices 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Conference on Harmonisation  
IRB 
Institutional Review Board 
ITT 
Intention-To-Treat 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
 
10.4 PROTOCOL AMENDMENT HISTORY 
N/A  
 
 
 

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Longo, V.D. and M.P. Mattson, Fasting: molecular mechanisms and clinical applications. Cell Metab, 2014. 
19(2): p. 181-92. 
2. 
Chaix, A., et al., Time-Restricted Feeding Prevents Obesity and Metabolic Syndrome in Mice Lacking a 
Circadian Clock. Cell Metab, 2018. 
3. 
Tinsley, G.M. and P.M. La Bounty, Effects of intermittent fasting on body composition and clinical health 
markers in humans. Nutr Rev, 2015. 73(10): p. 661-74. 
4. 
Brandhorst, S., et al., A Periodic Diet that Mimics Fasting Promotes Multi-System Regeneration, Enhanced 
Cognitive Performance, and Healthspan. Cell Metab, 2015. 22(1): p. 86-99. 
5. 
Wei, M., et al., Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and 
cardiovascular disease. Sci Transl Med, 2017. 9(377). 
6. 
Fontana, L., et al., Calorie restriction or exercise: effects on coronary heart disease risk factors. A 
randomized, controlled trial. Am J Physiol Endocrinol Metab, 2007. 293(1): p. E197-202. 
7. 
Lefevre, M., et al., Caloric restriction alone and with exercise improves CVD risk in healthy non-obese 
individuals. Atherosclerosis, 2009. 203(1): p. 206-13. 
8. 
Cheng, C.W., et al., Fasting-Mimicking Diet Promotes Ngn3-Driven beta-Cell Regeneration to Reverse 
Diabetes. Cell, 2017. 168(5): p. 775-788 e12. 
9. 
Rimm, E.B., et al., Cigarette smoking and the risk of diabetes in women. Am J Public Health, 1993. 83(2): p. 
211-4. 
10. 
Chavarro, J.E., et al., Contributions of the Nurses' Health Studies to Reproductive Health Research. Am J 
Public Health, 2016. 106(9): p. 1669-76. 
11. 
Cunha, T.F., et al., Exercise training prevents oxidative stress and ubiquitin-proteasome system overactivity 
and reverse skeletal muscle atrophy in heart failure. PLoS One, 2012. 7(8): p. e41701. 
12. 
Sargent, F., 2nd and R. Passmore, Normal variations in total ketone bodies in serum and urine of healthy 
young men. Q J Exp Physiol Cogn Med Sci, 1958. 43(4): p. 339-44.