Dietary Supplementation on Gastrointestinal Barrier Function

ABSTRACT

ConditionIntestinal Permeability

InterventionDietary Supplement plant derived phenolics;Other Microcrystaline cellulose (MCC)

Primary outcome:0-2 h urine 13C Mannitol excretion

Criteria
Inclusion Criteria

1. Male or female, 30-69 years of age, inclusive at Visit 1 (Day -7).

2. BMI of =29.0 to <40.0 kg/m2 at Visit 1 (Day -7).

3. Waist circumference >102 cm for men and >88 cm for women.

4. Non-user or former user (cessation =12 months) of tobacco or nicotine products (e.g.,
cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the
study period.

5. Non-user of marijuana or hemp products within 6 months of Visit 1, with no plans to
begin use during the study period. A washout of 7 days is required for topical
products (e.g., lotions) and willing to refrain from use during the study.

6. Willing to maintain physical activity and exercise patterns, body weight, and habitual
diet throughout the trial.

7. Willing to refrain from exclusionary medications, supplements, and products throughout
the study.

8. No health conditions that would prevent him/her from fulfilling the study requirements
as judged by the Clinical Investigator on the basis of medical history and routine
laboratory test results.

9. Understands the study procedures and signs forms providing informed consent to
participate in the study and authorizes the release of relevant protected health
information to the Clinical Investigator.

Exclusion Criteria

1. Known sensitivity, intolerance, or allergy to any of the study products or their
excipients.

2. Abnormal chemistry or hematology laboratory test result(s) of clinical significance at
Visit 1 (Day -7), at the discretion of the Clinical Investigator. One re-test will be
allowed on a separate day prior to Visit 2 (Day 0), for subjects with abnormal
laboratory test results.

3. Clinically important diagnosed GI condition that would potentially interfere with the
evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel
syndrome, gastroparesis / malabsorption conditions, eosinophilic disorders of the GI
tract, and clinically significant lactose or gluten intolerance or other food
allergies).

4. Recent (within 2 weeks of Visit 1; Day -7) history of an episode of acute GI illness
such as nausea/vomiting or diarrhea (defined as =3 loose or liquid stools/d).

5. Self-reported history (within 6 weeks of Visit 1; Day -7) of constipation (defined as
<3 bowel movements per week).

6. Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma),
cardiac (including, but not limited to, atherosclerotic disease, history of myocardial
infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including
Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (e.g.,
Parkinson's disease, multiple sclerosis, etc.), psychiatric (including depression
and/or anxiety disorders) or biliary disorders. Conditions which are well-controlled
or resolved will be assessed by the Clinical Investigator on a case-by-case basis.

7. Uncontrolled hypertension (systolic blood pressure =140 mm Hg or diastolic blood
pressure =90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -7).
Stable use of hypertension medication is allowed [defined as no change in medication
regimen within the 3 months prior to Visit 1 (Day -7)].

8. Received a COVID-19 vaccine within 2 weeks of Visit 1 (Day -7) or expect to receive a
COVID-19 vaccine during the study period.

9. Received an influenza vaccine within 1 week of Visit 1 (Day -7). Influenza vaccine is
allowed during the study but must not be received within 7 days prior to a study
visit.

10. Had a positive SARS-CoV2 test and experienced symptoms for >2 months (i.e.,
"long-haulers").

11. Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber,
vegan/vegetarian) at the discretion of the Clinical Investigator.

12. History or presence of cancer (including any malignant GI polyps) within 2 years of
Visit 1 (Day -7), except for non-melanoma skin cancer.

13. Major trauma or any other surgical event, including abdominal surgery which might
influence GI function, within 3 months of Visit 1 (Day -7).

14. Signs or symptoms of an active infection of clinical relevance* within 5 days of Visit
1 (Day -7). The visit may be rescheduled such that all signs and symptoms have
resolved (at the discretion of the Clinical Investigator) at least 5 days prior to
Visit 1 (Day -7).

15. Antibiotic use within 1 month of Visit 1 (Day -7) and throughout the study period.

16. Regular use (i.e., >3 days/week) of anti-inflammatory medications (e.g., NSAIDS)
within 1 month of Visit 1 (Day -7).

17. Use of medications (over-the-counter or prescription) and/or dietary supplements known
to influence GI function, including but not limited to, pre- and probiotic supplements
as well as foods or beverages containing live probiotics (e.g., yogurt, kombucha),
fiber supplements, laxatives, enemas, suppositories, histamine H2 receptor
antagonists, proton pump inhibitors, antacids, anti-diarrheal agents, and/or
anti-spasmodic within 2 weeks of Visit 1 (Day -7) and throughout the study period.
Standard multivitamin and mineral supplements are allowed.

18. Had a colonoscopy or endoscopy within 1 month prior to Visit 1 (Day -7).

19. Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Day -7).

20. Female who is pregnant, planning to be pregnant during the study period, lactating, or
is of childbearing potential and is unwilling to commit to the use of a medically
approved form of contraception throughout the study period. Subjects who are pregnant
during the study will be discontinued.

21. Female subjects who is unwilling to wear a tampon during the collection of the 24-h
urine samples when these collections occur during the time of menstruation

22. Recent history (within 12 months of screening; Visit 1; Day -7) of alcohol or
substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz
beer, 5 oz wine, or 1½ oz distilled spirits).

23. Has a condition the Clinical Investigator believes would interfere with his ability to
provide informed consent, comply with the study protocol, which might confound the
interpretation of the study results, or put the subject at undue risk.

- If an infection occurs during the study period, test visits will be rescheduled
until signs and symptoms have resolved (at the discretion of the Clinical
Investigator) at least 5 days prior to the scheduled study visits.