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

Sponsor

Baylor University (Other)

Overall Status

Completed

CT.gov ID

NCT04498455

Collaborator

(none)

Enrollment

Location

Arms

4.5

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Gain Trajectory Metabolic Syndrome	Dietary Supplement: Prebiotin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized placebo-controlled trial of a fiber supplement [Prebiotin] compared to placebo [maltodextrin]Randomized placebo-controlled trial of a fiber supplement [Prebiotin] compared to placebo [maltodextrin]

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 30, 2018

Actual Primary Completion Date :

Feb 14, 2019

Actual Study Completion Date :

Feb 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Dietary Supplement: Placebo	Dietary Supplement: Prebiotin Fructo-oligosaccharide dietary supplement powder
Active Comparator: Prebiotin Dietary Supplement: Prebiotin (oligofructose enriched inulin)	Dietary Supplement: Prebiotin Fructo-oligosaccharide dietary supplement powder

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Dietary Supplement: Placebo

Dietary Supplement: Prebiotin

Fructo-oligosaccharide dietary supplement powder

Active Comparator: Prebiotin

Dietary Supplement: Prebiotin (oligofructose enriched inulin)

Dietary Supplement: Prebiotin

Fructo-oligosaccharide dietary supplement powder

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.