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Active low dose of plant derived phenolics for Leaky Gut Syndrome

N/A

Recruiting

Research Sponsored by Brightseed

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, and 42 days

Awards & highlights

Study Summary

This trial aims to investigate how a dietary supplement with plant-derived phenolics at two different doses can improve gut health in healthy adults with risk factors for digestive issues. The main goal is to see if the

Who is the study for?

Adults aged 30-69 with a high BMI (29.0 to <40.0) and large waist circumference (>102 cm for men, >88 cm for women), who don't use tobacco or marijuana products, can join this trial. They must be willing to keep their diet, exercise, and weight stable throughout the study.Check my eligibility

What is being tested?

The trial is testing if taking dietary supplements with plant derived phenolics improves gut health in adults at risk of leaky gut syndrome due to obesity. Participants will receive either the supplement at two dose levels or a placebo.See study design

What are the potential side effects?

Potential side effects are not specified but may include typical reactions to dietary supplements such as digestive discomfort or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, and 42 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, and 42 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, and 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

0-2 h urine 13C Mannitol excretion

Secondary outcome measures

0 to 2 h urine LMR

2 to 8 h urine 13C Mannitol

2 to 8 h urine LMR

+7 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Active low dose of plant derived phenolicsActive Control1 Intervention

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

Group II: Active high dose of plant derived phenolicsActive Control1 Intervention

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

Group III: Placebo treatmentPlacebo Group1 Intervention

Placebo treatment (Microcrystaline cellulose): 1 capsule/d

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BrightseedLead Sponsor

2 Previous Clinical Trials

160 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of the patient cohort being observed in this clinical investigation?

"Yes, information on clinicaltrials.gov reveals that this medical trial is actively seeking participants. The study was first posted on February 6th, 2024 and last updated on March 6th, 2024. A total of 126 patients are sought from a single site."

Answered by AI

Are researchers currently seeking participants for this study?

"Indeed, as per clinicaltrials.gov data, this specific trial is actively seeking candidates. The initial posting date was 2/6/2024 with the most recent update on 3/6/2024. A total of 126 participants are sought from a single designated site."

Answered by AI

Is the scope of this medical study limited to individuals younger than 55 years old?

"To be considered for enrollment in this research endeavor, individuals must be between the ages of 30 and 69 years old."

Answered by AI

What are the eligibility criteria for participation in this clinical study?

"The clinical trial aims to enroll 126 individuals aged between 30 and 69 with leaky gut syndrome. To be eligible, participants must fulfill these conditions: Male or female between the ages of 30-69 at Visit 1 (Day -7), have a BMI ranging from ≥29.0 to <40.0 kg/m2 at Visit 1 (Day -7), agree to avoid specified medications, supplements, and products during the study period, possess a waist circumference exceeding >102 cm for men and >88 cm for women, commit to maintaining their current physical activity levels, body weight, and dietary habits throughout the duration"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dietary Supplementation on Gastrointestinal Barrier Function

2024. "Dietary Supplementation on Gastrointestinal Barrier Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06262880.

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