Dietary Supplementation on Gastrointestinal Barrier Function

Intestinal Permeability Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Effects of a Dietary Supplement Containing N-trans-Caffeoyltyramine (NCT) and N-trans-Feruloyltyramine (NFT) on Gastrointestinal Barrier Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262880
• Other study ID #: BIO-2305
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2024
• Est. completion date: February 6, 2025

Study information

• Verified date: March 2024
• Source: Brightseed
• Contact: Doug Bolster, PhD
• Phone: (720)527-4131
• Email: doug.bolster[@]brightseedbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels on parameters of gastrointestinal (GI) health in otherwise generally healthy adults with risk factors (high BMI and waist circumference) for increased GI permeability. The primary hypothesis is that supplementation with plant derived phenolics will improve gut health compared to placebo.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: February 6, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Permeability

Intervention

Dietary Supplement:
• plant derived phenolics
Dietary supplement containing plant derived phenolics

Other:
• Microcrystaline cellulose (MCC)
Placebo treatment: Microcrystaline cellulose

Locations

Country	Name	City	State
United States	Biofortis	Addison	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Brightseed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	0-2 h urine 13C Mannitol excretion	GI permeability will be assessed using a sugar probe (13C mannitol).	0, and 42 days
Secondary	2 to 8 h urine 13C Mannitol	GI permeability will be assessed using a sugar probe (13C mannitol).	0, and 42 days
Secondary	0 to 2 h urine LMR	GI permeability will be assessed using a two-sugar (lactulose and 13C mannitol) probe procedure.	0, and 42 days
Secondary	2 to 8 h urine LMR	GI permeability will be assessed using a two-sugar (lactulose and 13C mannitol) probe procedure. Two pooled urine samples (0-2 h and 2:01-8 h) will be collected over an 8 h period for subsequent analysis at Clinic.	0, and 42 days
Secondary	Blood Biomarkers	Soluble CD14	0, and 42 days
Secondary	Blood Biomarkers	LBP	0, and 42 days
Secondary	Blood Biomarkers	I-FABP	0, and 42 days
Secondary	Fecal Biomarkers	Secretory IgA	0, and 42 days
Secondary	Fecal Biomarkers	Calprotectin	0, and 42 days
Secondary	Inflammatory Biomarkers (Blood)	hsCRP	0, and 42 days
Secondary	Inflammatory Biomarkers (Blood)	IL-1ß	0, and 42 days
Secondary	Inflammatory Biomarkers (Blood)	TNF-a	0, and 42 days
Secondary	Inflammatory Biomarkers (Blood)	IL-6	0, and 42 days
Secondary	7-day recall of gastrointestinal symptoms	Composite score of GITQ (sum of all 8 individual scores) Individual symptom GITQ score	0, and 42 days
Secondary	7-day recall of gastrointestinal symptoms	Individual symptom GITQ score	0, and 42 days
Secondary	Stool frequency	Bristol stool scale	0, and 42 days
Secondary	Stool consistency	Bristol stool scale	0, and 42 days
Secondary	Body Weight	Body Weight in kg.	0, and 42 days