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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 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

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Who is running the clinical trial?

BrightseedLead Sponsor
3 Previous Clinical Trials
290 Total Patients Enrolled
~76 spots leftby Dec 2024
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