Dietary Supplementation on Gastrointestinal Barrier Function

NCT06262880 | Recruiting

• 1 other identifier: BIO-2305
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intestinal Permeability

Outcome Measures

Primary Outcomes (1)

• 0-2 h urine 13C Mannitol excretion

  GI permeability will be assessed using a sugar probe (13C mannitol).

  0, and 42 days

Secondary Outcomes (17)

• 2 to 8 h urine 13C Mannitol

  0, and 42 days

• 0 to 2 h urine LMR

  0, and 42 days

• 2 to 8 h urine LMR

  0, and 42 days

• Blood Biomarkers

  0, and 42 days

• Blood Biomarkers

  0, and 42 days

Study Arms (3)

Placebo treatment

PLACEBO COMPARATOR

Placebo treatment (Microcrystaline cellulose): 1 capsule/d

Other: Microcrystaline cellulose (MCC)

Active low dose of plant derived phenolics

ACTIVE COMPARATOR

Active low dose of plant derived phenolics via 1 capsule/d

Dietary Supplement: plant derived phenolics

Active high dose of plant derived phenolics

ACTIVE COMPARATOR

Active high dose of plant derived phenolics via 1 capsule/d

Dietary Supplement: plant derived phenolics

Interventions

plant derived phenolics DIETARY_SUPPLEMENT

Dietary supplement containing plant derived phenolics

Active high dose of plant derived phenolics; Active low dose of plant derived phenolics

Microcrystaline cellulose (MCC) OTHER

Placebo treatment: Microcrystaline cellulose

Placebo treatment

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 30-69 years of age, inclusive at Visit 1 (Day -7).
• BMI of ≥29.0 to \<40.0 kg/m2 at Visit 1 (Day -7).
• Waist circumference \>102 cm for men and \>88 cm for women.
• 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.
• 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.
• Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial.
• 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.
• 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.

You may not qualify if:

• Known sensitivity, intolerance, or allergy to any of the study products or their excipients.
• 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.
• 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).
• 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).
• Self-reported history (within 6 weeks of Visit 1; Day -7) of constipation (defined as \<3 bowel movements per week).
• 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.
• 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 \[defined as no change in medication regimen within the 3 months prior to Visit 1 (Day -7)\].
• 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.
• 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.
• Had a positive SARS-CoV2 test and experienced symptoms for \>2 months (i.e., "long-haulers").
• Extreme dietary habits (e.g., ketogenic, very high protein, very high fiber, vegan/vegetarian) at the discretion of the Clinical Investigator.
• History or presence of cancer (including any malignant GI polyps) within 2 years of Visit 1 (Day -7), except for non-melanoma skin cancer.
• Major trauma or any other surgical event, including abdominal surgery which might influence GI function, within 3 months of Visit 1 (Day -7).
• 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).
• Antibiotic use within 1 month of Visit 1 (Day -7) and throughout the study period.

Sponsors & Collaborators

• Brightseed: lead

Study Sites (1)

Biofortis

Addison, Illinois, 60101, United States

RECRUITING

MeSH Terms

Interventions

microcrystalline cellulose

Central Study Contacts

Doug Bolster, PhD

CONTACT

(720)527-4131; doug.bolster@brightseedbio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 16, 2024
• Study Start: February 6, 2024
• Primary Completion: December 20, 2024
• Study Completion: February 6, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

US (1)