A Single-Group Study to Examine the Efficacy of a Gut Health Supplement to Increase Metabolism, Improve Gut Health, and Support Weight Management
Phase: NA
Conditions: Gut Health, Metabolism, Weight Loss, Energy
Sponsor: Gut Health, UAB

 
 
 
A Single-Group Study to Examine the Efficacy of a Gut 
Health Supplement to Increase Metabolism, Improve 
Gut Health, and Support Weight Management 
 
 
Protocol Number: 20349 
National Clinical Trial (NCT) Identified Number:  NCT06023082  
Principal Investigator: Christopher Hill, Ph.D, Ellen O'Gorman, MSc. 
Sponsor: Gut Health, UAB 
Clinical Research Organization: Citruslabs 
Version Number:  v.1.0 
30 May 2023 
 
 
 
 
 
 
Summary of Changes from Previous Version: 
 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
 
 
STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with International Conference on Harmonisation 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.  The protocol and 
consent form must be approved before enrolling any participant.  Any amendment to the 
protocol will require 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. 
 
 
 

3 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
A Single-Group Study to Examine the Efficacy of a Gut Health 
Supplement to Increase Metabolism, Improve Gut Health, and 
Support Weight Management 
 
Study Description: 
 
This study will evaluate the efficacy of Colon Broom Premium on gut 
health, metabolism, weight management, and energy levels. The 
study will be conducted as a virtual single-group trial in which all 120 
participants will use the test product. This study will last 12 weeks, 
and participants will take the product daily. Participants will complete 
study-specific questionnaires at Baseline, Week 1, Week 2, Week 3, 
Week 4, Week 6, Week 8, Week 10, and Week 12. Participants will 
also provide body weight measurements and body circumference 
measurements at Baseline, Week 1, Week 2, Week 3, Week 4, Week 
6, Week 8, Week 10, and Week 12.  
Before & after photographs will be provided at Baseline and Week 12.  
 
The Colon Broom Premium supplement contains  
psyllium seed husk powder, L-carnitine tartrate, CapsimaxⓇ cayenne 
fruit extract, chromium (as chromium picolinate), vitamin B6 (as 
pyridoxine HCl), vitamin B12 (as cyanocobalamin), and Iron. 
 
The study Sponsor and product name will remain anonymous to 
participants throughout the trial. The Sponsor name or product name 
will not be included in any participant-facing documentation.    
 
Objectives: 
Primary Objective: To examine Colon Broom Premium's effect on 
improving gut health and metabolism.  
 
Secondary Objective: To determine the effects of Colon Broom 
Premium on weight management.  
 
Endpoints: 
Primary Endpoint: Improvement in gut health issues and metabolism. 
This will be measured through study-specific questionnaires, 
evaluating bowel movement regularity, satiety, energy levels, and 
gastrointestinal symptoms such as gas, bloating, constipation, 
heartburn/acid reflux, abdominal pain, and digestion.  
 
Secondary Endpoints: Weight management will be evaluated via 
weigh-ins, body measurements, questionnaires, and before-and-after 
photos. 
 

4 
Study Population: 
120 men and women ages 30 - 50 with a minimum BMI of 25.0. 
Description of 
Sites/Facilities 
Enrolling 
Participants: 
Virtual trial. Enrollment, questionnaires, photos, measurements, and 
weigh-ins will be completed virtually.  
Description of 
Study Intervention: 
A virtual single-group Colon Broom Premium supplement trial. 
Assessments will be conducted virtually through questionnaires 
completed at Baseline and then Week 1, Week 2, Week 3, Week 4, 
Week 6, Week 8, Week 10, and Week 12.  Body measurements and 
weight measurements will also be taken at Week 1, Week 2, Week 3, 
Week 4, Week 6, Week 8, Week 10, and Week 12. Photos will be 
taken at Baseline and at Week 12. 
Study Duration: 
12 weeks 
Participant 
Duration: 
12 weeks 
 
 
 
 
1.2 
SCHEMA 
Prior to  
Enrollment 
 
 
 
 
Intervention 
 
 
 
 
 
Total N=120. Obtain informed consent. Screen potential participants by inclusion and 
exclusion criteria; obtain history, document. Participants complete baseline survey, take 
before-and-after photos, and measure weight, and take body measurements. 
 
Study period - 12 weeks 
Participants will complete a baseline questionnaire, take baseline photos, and complete 
their first weigh-in/body measurement. 
Participants will begin using their allocated products as directed: 
ALL PARTICIPANTS: 
Add 1 scoop (0.23 oz/ 6.47 g) to 12-14 fl oz of water, mix well and drink immediately. 
Take supplement 30 -60 minutes before your meal. Then drink an additional glass of 
water. Do not take supplement less than 2 hours before bedtime. Test product may be 
consumed before breakfast, lunch, or dinner.  
 
First week: Start with 1 serving per day  
Rest of the study period: Increase to 2 servings per day at 2 different times during the 
day.  
 
P
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Final Assessments 
Statistical analysis performed 

5 
1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
 
Procedures 
Screening 
Intervention 
Conclusion 
Informed Consent 
x 
 
 
Demographics 
x 
 
 
Inclusion/ Exclusion 
x 
 
 
Administer Study 
Intervention 
 
x 
 
Surveys 
x 
x 
x 
Photos 
x 
 
x 
Weigh-Ins 
x 
x 
x 
Body 
Measurements 
x 
x 
x 
Adverse event 
Review and 
Evaluation 
x 
x 
x 
 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
Digestive issues plague nearly 60 - 70 million people worldwide, and in the past ten years, 
diseases and disorders related to the gastrointestinal system have increased due to significant 
lifestyle changes1. Furthermore, several studies have documented a high prevalence of 
depression, stress, anxiety, and altered central nervous system processing among people with 
gastrointestinal issues2. 
 
The gut microbiome is a crucial factor in the pathogenesis of most gut issues, as well as having 
an important role to play in the development of obesity, energy maintenance, and 
immunoresponse3. 
 
Therefore, maintaining the gastrointestinal microbiome is vital to a healthy gut system and weight. 
Dietary fibers affect the gut microbiome and play essential roles in signaling pathways, regulating 
appetite, inflammation, glucose metabolism, gut integrity, and the body’s immune response4. 
 
The Colon Broom Premium Supplement is a natural, plant-based dietary fiber complex that helps 
to promote digestive health, assist in weight loss, and relieve constipation. The supplement 
contains: 

6 
Psyllium husk: Commonly used fiber as a gentle, bulk-forming laxative. Psyllium husk can pass 
through the digestive system without being completely broken down or absorbed. Instead, it 
absorbs water and becomes a viscous compound that alleviates constipation and diarrhea, helps 
to control blood sugar and blood pressure, and benefits weight loss. 
 
L-carnitine: L-carnitine can assist with physical performance and muscle recovery after exercise. 
 
CapsimaxⓇ Cayenne Fruit Extract: Capsimax is a concentrated natural capsicum extract from 
red hot chili peppers. Capsaicinoids found in chili peppers and pepper extracts have been found 
to enhance metabolism and assist in weight loss5. 
 
Chromium (as Chromium Picolinate): Chromium is an essential human micronutrient. Some 
take it as a supplement for a complementary and alternative therapy to help control blood sugar 
levels, lower cholesterol, or lose weight6.  
 
The product also contains vitamins B6, B12, and iron to assist in maintaining a healthy body and 
improving mental health. 
 
This trial examines the efficacy of the Colon Broom Premium supplement in improving gut health, 
metabolism, weight loss, and mental health outcomes. This study will include 120 participants 
using the test product for 12 weeks. The trial will last 12 weeks, and the participants will record 
self-perceived outcomes, weight, and body measurements at Baseline and then at Week 1, Week 
2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12. In addition, participants will take 
photos at Baseline and Week 12. 
 
2.2 
RISK/BENEFIT ASSESSMENT   
 
 
Immediate risks: There are no expected immediate risks for participants using this supplement; 
however, some users may experience some changes in bowel movement or feel bloated as the 
body adjusts to the increased fiber intake. 
 
Long-term risks: There are no expected long-term risks for participants using this supplement. 
 
Immediate benefits: Participants may see benefits to overall health and gut health (reduced 
constipation, regular bowel movements, feeling lighter, less gas, decreased bloating). 
Furthermore, participants may feel more energetic with improved mood, focus, energy, and 
weight reduction. 
 
Long-term benefits: Participants may see benefits to overall health and gut health (reduced 
constipation, regular bowel movements, feeling lighter, less gas, decreased bloating). Over 
time, the immediate benefits can improve the overall quality of life and ability to complete 
activities of daily living.  
 
 
 
 

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3 
OBJECTIVES AND ENDPOINTS 
 
 
OBJECTIVES 
ENDPOINTS 
TIMEPOINTS 
ASSESSED 
BY 
JUSTIFICATION 
FOR 
ENDPOINTS 
Primary 
To examine 
the effect of 
Colon Broom 
Premium 
Supplement 
on gut health 
and 
metabolism. 
Questionnaires 
Baseline, Week 
1, Week 2, 
Week 3, Week 
4, Week 6, 
Week 8, Week 
10, and Week 
12. 
Self-reported 
questionnaire 
To evaluate the 
perceived effects 
of the treatments 
on gut health 
and metabolism 
Secondary 
To examine 
changes in 
weight and 
body 
measurement
s, and overall 
health   
Photos 
 
Baseline and 
Week 12 
Virtual grading 
of body size 
To identify visual 
changes in 
weight 
Questionnaires 
Baseline, Week 
1, Week 2, 
Week 3, Week 
4, Week 6, 
Week 8, Week 
10, and Week 
12. 
Self-reported 
questionnaire 
To evaluate the 
perceived effects 
of the treatments 
on weight and 
overall health 
Body weight 
measurements 
Baseline, Week 
1, Week 2, 
Week 3, Week 
4, Week 6, 
Week 8, Week 
10, and Week 
12. 
Self-reported 
weight and 
tape 
measurement
s 
To evaluate the 
effects of the 
treatments on 
weight and body 
size. 
Tape measurements of the 
body 
 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
 
This study is a single-group trial with 120 participants with gut health issues and who are 
overweight. Participants will take a Colon Broom Premium supplement daily for 12 weeks. 
Participants will provide questionnaires, weight measurements, body measurements, and 
photos at baseline before the study starts. Follow-up questionnaires, weight measurements and 
body measurements will be completed at the end of Week 1, Week 2, Week 3, Week 4, Week 
6, Week 8, Week 10, and Week 12. At the end of Week 12, participants will also take final 
photos, marking the end of the study. The trial will be a virtual study, and the participants will 
follow the product use instructions provided by the research team.  

8 
 
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
A single-group study is an appropriate design best to understand the efficacy and safety of the 
test product. A design that encompasses 12 weeks is also long enough to determine if the 
supplement is effective at improving gut health and measuring changes to weight and size 
beyond short-term fluctuations that may occur. The data collection intervals for this trial were 
chosen to minimize the burden on the patients (i.e., not having to travel to a clinic) while still 
collecting valuable data about the efficacy of the test product over time. 
 
 
4.3 
JUSTIFICATION FOR DOSE 
 
The test product examined in this study will be taken in the exact dosages of the commercially 
available products. This will be done to help establish marketing claims that can be used with 
the test product and to understand the current formulation of the test product. 
 
 
4.4 
END OF STUDY DEFINITION 
 
A participant is considered to have completed the trial if he or she has completed all study 
phases, including the last scheduled procedure (Week 12 questionnaire, weigh-in, body 
measurements, and photos). 
 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
To be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Male or female between ages 30-50  
2. Have a BMI of 25 or more 
3. Have self-reported issues with gas, bloating, constipation, heartburn/acid reflux, 
abdominal pain, or digestion at least three times per week 
4. Be willing to maintain their standard dietary pattern, activity level, and body weight for 
the duration of the study 
5. Be generally healthy - do not live with any uncontrolled chronic disease 
 
 
5.2 
EXCLUSION CRITERIA 
An individual who meets the following criteria will be excluded from participation in this study: 
1. Any pre-existing chronic conditions that would prevent participants from adhering to the 
protocol, including oncological and psychiatric disorders 
2. Anyone who is currently undergoing, or planning to to undergo any gut or weight-related 
procedures in the next 12 week. 
3. Anyone with a history of severe allergic reactions including but not limited to psyllium 
seed husk powder and strawberries 
4. Anyone taking any prescription medications targeting the gut 

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5. Anyone taking any supplements targeting the gut in the past month 
6. Use of antibiotics in the past 3 months 
7. Women who are pregnant, breastfeeding, or attempting to become pregnant 
8. Anyone unwilling to follow the study protocol 
9. Anyone following any particular dietary regime, such as a ketogenic diet or intermittent 
fasting. 
10. Anyone who has had bariatric surgery in the past 6 months 
11. Anyone who has chronic constipation 
12. Anyone who has Irritable Bowel Disease (IBD) 
13. Anyone diagnosed with severe digestive issues 
 
 
5.3 
PARTICIPANT COMPENSATION 
 
All participants will be compensated $75 for their time and effort in the form of a prepaid VISA 
card.  
 
 
5.4 
JUSTIFICATION OF SAMPLE SIZE 
 
120 participants is sufficient to establish differences between baseline and endline while 
accounting for the natural variance in different people. This will allow for meaningful 
comparisons between baseline and endline to test the efficacy of the Colon Broom supplement 
adequately. 
 
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION  
 
Potential participants who meet the initial inclusion and exclusion criteria will have the option of 
participating in this trial. After signing the informed consent, participants will begin the trial by 
taking the initial baseline survey, taking baseline photos, conducting the initial weigh-in, and 
taking baseline body measurements. 
 
After the baseline data collection, participants will begin using their allocated products. 
 
● Participants will be sent 3 containers of Colon Broom Premium containing 60 scoops per 
container, amounting to a minimum of 180 scoops over the 12-week period 
● The product should be taken as follows: 
○ Participants will add 1 scoop (0.23 oz / 6.47 g) to 12-14 fl oz of water, mix well and 
drink 30 - 60 minutes before eating.  
○ The supplements should be consumed immediately after preparation and followed 
by an additional glass of water. 
○ Participants should not take the supplement less than 2 hours before bedtime.  
○ Participants should start with 1 serving per day for the first week, then increase to 
2 servings per day after that. 

10 
● Participants will complete questionnaires at Baseline, Week 1, Week 2, Week 3, Week 4, 
Week 6, Week 8, Week 10, and Week 12.  
● Participants will complete weigh-ins and body measurements at baseline and at Week 1, 
Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, and Week 12.  
● Participants will complete “before” photos at baseline and “after” photos at endline (Week 
12). This will mark the conclusion of the trial. 
   
 
6.2 
INTERVENTION FORMULATION 
 
The product contains the following ingredients: 
● Psyllium Seed Husk Powder 
● L-Carnitine Tartrate 
● Capsimax® Cayenne Fruit Extract 
● Chromium (as Chromium Picolinate) 
● Vitamin B6 (as Pyridoxine HCl) 
● Vitamin B12 (as Cyanocobalamin) 
● Iron  
 
 
 
6.3 
RANDOMIZATION AND BLINDING 
 
The study Sponsor and product name will remain anonymous to participants throughout the 
trial. The Sponsor name or product name will not be included in any participant-facing 
documentation. There is no randomization for this study.  
 

11 
6.4 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants can withdraw from the study at any time upon request. 
An investigator may discontinue or withdraw a participant from the study for the following 
reasons: 
 
● Pregnancy 
● Significant study intervention non-compliance  
● If any clinical adverse event (AE), laboratory 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 
● Disease progression which requires discontinuation of the study intervention 
● If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
● Participant should be withdrawn from study if they start on a new drug or receive 
antibiotics 
 
The reason for participant discontinuation or withdrawal from the study will be recorded on a 
Case Report Form (CRF). Participants who sign the informed consent form but do not receive 
the study intervention may be replaced.  Participants who sign the informed consent form,  
receive the study intervention, and subsequently withdraw or are withdrawn or discontinued 
from the study, will not be replaced. 
 
6.5 
PHOTO INSTRUCTIONS 
 
The photos taken during this study will be used to track weight loss. 
Participants will provide photos at the following time points during the study: 
● Baseline (Week 0) 
● Endline (Week 12) 
At baseline and endline, participants will take three photos from their chin down to their knees  at 
the following angles: front-facing, side profile, and facing backward.  
  Photo guidelines: 
● Have someone take the photos for you if possible 
● Flash OFF 
● Wearing underwear if comfortable (tight clothing if not comfortable wearing underwear) 
● The photo should include the entire area between the chin and the knees of the 
participants 
● Take three photos (front-facing, side profile, back-facing) 
● Take photos in a well-lit room without shadows 
● Take photos in the same location at the same time 
6.6 
BODY MEASUREMENTS 

12 
 
The body measurements taken during this study will be used to track weight loss. Participants will 
receive a tape measure to gather their measurements.  
Participants will provide measurements at the following time points during the study: 
● Baseline (Week 0) 
● Week 1 
● Week 2 
● Week 3 
● Week 4 
● Week 6 
● Week 8 
● Week 10 
● Endline (Week 12) 
Participants will measure the following areas: 
● Waist  
● Hips 
● Legs (thighs) 
Participants must adhere to the following instructions when taking measurements: 
● To ensure accurate measurements, wear tight-fitting or form-fitting clothing or wear your 
undergarments while measuring. This will help you get precise measurements without any 
bulky layers of clothing distorting the measurements. 
● Stand up straight with your feet shoulder-width apart. Relax your body and keep your arms 
at your sides. It may be useful to do this in front of a mirror.  
Measure your waist: 
● First, locate your natural waist which is the narrowest part of your torso. This is usually 
located just above your belly button. 
● Start by wrapping the measuring tape around your waist. Hold one end of the tape against 
your body at your natural waist and bring the other end around your waist, keeping it 
parallel to the floor. Ensure that the tape is snug against your body without digging into 
your skin or compressing it. Make sure the tape is level and not twisted. 
● Exhale and take the measurement: Once the tape is in position, take a normal breath and 
then exhale. Read the measurement at the point where the end of the tape meets the rest 
of the tape around your waist. Take note of the measurement in inches.  
Measure your hips: 
● First, locate the widest part of your hips. The hip measurement should be taken at the 
fullest part of your buttocks and hips. 
● Start by wrapping the measuring tape around your hips. Hold one end of the tape against 
your body at the fullest part of your hips and buttocks. Bring the other end of the tape 
around your hips, making sure it remains parallel to the floor. The tape should go over the 
largest part of your buttocks. 

13 
● Take the measurement by reading the point where the end of the tape meets the rest of 
the tape. Note down the measurement in inches. Ensure that the tape is snug against your 
body without being too tight.  
Measure your thighs: 
● First, locate the widest part of your upper thigh on both legs. This is where you will take 
your measurement.  
● Wrap the measuring tape around your thigh: Hold one end of the tape against your thigh 
at the chosen point and wrap the tape around your thigh, keeping it parallel to the floor. 
Make sure the tape is snug against your skin without digging in or compressing your thigh. 
● Take the measurement by reading the point where the end of the tape meets the rest of 
the tape. Note down the measurement in inches.  
 
 
6.7 
DEVICES  
 
Participants must have access to a body weight scale and a smartphone or digital camera for the 
duration of the study. Participants will be provided with a measuring tape.  
 
7 
STATISTICAL CONSIDERATIONS  
Following data collection and the completion of the trial, the data will be analyzed by Citruslabs 
to determine the effect of the intervention. Participant repeated measures between time point 
statistical tests will be used to examine differences in gut health, weight, metabolism, and 
mental health. Percentages of people who experienced improvements will also be examined. 
 
 
8 
CONSENT, PRIVACY AND OTHER POLICIES 
 
8.1 
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 before starting 
intervention/administering study intervention.  The following consent materials are submitted 
with this protocol: informed consent form and patient bill of rights. 
 
8.2 
CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated before the individual agrees to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be 
approved by Institutional Review Board (IRB), and the participant will be asked to read and 
review the document. These documents will explain the research study to the participant and 
answer any questions that may arise. A verbal or written 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 be able to carefully review the 
written consent form and ask questions before signing. The participants should have the 

14 
opportunity to discuss the study with their family or surrogates or think about it before agreeing 
to participate. The participant will sign the informed consent document prior to any procedures 
being done specifically for the study. Participants must be informed that participation is 
voluntary and that they may withdraw from the study at any time, without prejudice. The 
participants will be given a copy of the informed consent document 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. 
The rights and welfare of the participants will be protected by emphasizing to them that the 
quality of their medical care will not be adversely affected if they decline to participate in this 
study. 
 
 
 
8.3 
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 (not applicable to this study). 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 third party without prior written approval of the 
sponsor.  
 
The study participant’s contact information and records will be securely stored on an AWS 
server. At the end of the study, all records will remain in a secure location for as long a period 
as dictated by the reviewing IRB, Institutional policies, or sponsor requirements. 
 
 
8.4 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of Citruslabs, which ensures the accuracy, completeness, 
legibility, and timeliness of the data reported. 
 
Trial data will be entered into a 21 CFR Part 11-compliant data capture system provided by 
Citrus Labs. The data system includes password protection and internal quality checks, such as 
automatic range checks, to identify inconsistent, incomplete, or inaccurate data. Clinical data 
will be entered directly from the source documents. 
 
8.5 
PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol, International 
Conference on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures 
(MOP) requirements. The noncompliance may be either on the part of the participant, the 
investigator, or the CRO staff. As a result of deviations, corrective actions are to be developed 
by the trial administrator (Citruslabs) and implemented promptly.  
 
It is the responsibility of Citruslabs to use continuous vigilance to identify and report deviations 
within 7 working days of identification of the protocol deviation, or within 7 working days of the 
scheduled protocol-required activity. Protocol deviations must be sent to the reviewing 
Institutional Review Board (IRB) per their policies. Citruslabs is responsible for knowing and 
adhering to the reviewing IRB requirements. 
 

15 
 
8.6 
PUBLICATION AND DATA SHARING POLICY 
This study will be conducted in accordance with the following publication and data sharing 
policies: the study may be published in an open-access preprint server. The study 
administrators (Citruslabs) will be acknowledged in any publications relating to this study. This 
trial may be registered with clinicaltrials.gov and results may be submitted to clinicaltrials.gov 
following publication. No part of this study, including protocol and results, may be published in 
any form without explicit prior approval in writing by the study sponsor. 
 
 
 
8.7 
CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence is critical.  Therefore, any 
actual conflict of interest of persons who have a role in the design, conduct, analysis, 
publication, or any aspect of this trial will be disclosed and managed. Furthermore, persons who 
have a perceived conflict of interest will be required to have such conflicts managed in a way 
that is appropriate to their participation in the design and conduct of this trial.   
 
The sponsor has a conflict of interest because they may benefit financially from the study's 
success. To manage the conflict of interest, an independent third party (Citrusabs) will handle all 
design and administration of participant-focused materials, all participant recruitment and data 
gathering, and data analysis. 
 

16 
9 
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Gut 
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at: 
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5) Rogers, J., Urbina, S.L., Taylor, L.W., Wilborn, C.D., Purpura, M., Jager, R., Juturu, V. 
(2018). Capsaicinoids supplementation decreases percent body fat and fat mass: 
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6) Tian, H., Guo, X., Wang, X., He, Z., Sun, R., Ge, S., Zhang, Z. (2013). Chromium picolinate 
supplementation for overweight or obese adults. Cochrane Database System Reviews. 
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