Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency

Phase 4

Completed

• Conditions: Weight Gain Trajectory; Metabolic Syndrome
• Interventions: Dietary Supplement: Prebiotin

• Registration Number: NCT04498455
• Lead Sponsor: Baylor University

Brief Summary

A randomized placebo controlled trial to determine if increased dietary fiber will prevent weight gain, inhibit adiposity and reduce perceived stress levels in residents at the Waco Family Health Center as the result of changes in distal gut microbiota composition and function.

Detailed Description

This study will utilize a single blind, placebo controlled, parallel design to assess the effect of dietary fiber \[Prebiotin\] on the gut microbiome, perceived stress, anthropometric variables, and clinical biomarkers of metabolism. All participants in this study will be resident physicians at the Family Health Center in Waco, TX. This population was selected based on pilot data indicating they are at a greater risk for weight gain and have higher levels of stress than the average population. The goal is to recruit 40 participants for a 12 week intervention trial.

Study Timeline

• Study Start: 2018-09-30
• Primary Completion: 2019-02-14
• Study Completion: 2019-02-15
• Study First Submitted: 2020-07-30
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-04
• Last Update Submitted: 2020-08-13
• Last Update Posted: 2020-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Currently a resident in training at the Family Health Center in their first year.

Exclusion Criteria

• Pregnancy
• Currently on prescribed metformin or NSAIDS
• A diagnosed gastro-intestinal disease (i.e. irritable bowel syndrome or Crohn's disease)
• Known allergy to the supplement, placebo, or provided meal replacements
• Antibiotic use within the last 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Prebiotin	Dietary Supplement: Placebo
Prebiotin	Prebiotin	Dietary Supplement: Prebiotin (oligofructose enriched inulin)

Primary Outcome Measures

Name	Time	Method
Change in body weight	12 weeks	The investigators will use the following procedure to assess the effect of Prebiotin (OEI) on changes in body weight: there will be two test days: a) baseline (Day 0), prior to randomization to OEI or placebo; and b) week 12, following the 11 week course of OEI/placebo treatment. The investigators will use OEI for the inulin challenge. Change in body weight will be quantified by bio electrical impedance.

Trial Locations

Locations (1)

Baylor University; 🇺🇸 Waco, Texas, United States