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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Weight Gain Trajectory, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Prebiotin


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized placebo-controlled trial of a fiber supplement [Prebiotin] compared to placebo [maltodextrin]
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Dietary Supplement: Placebo | Dietary Supplement: Prebiotin<br>* Fructo-oligosaccharide dietary supplement powder<br>|
| Active Comparator: Prebiotin<br>Dietary Supplement: Prebiotin (oligofructose enriched inulin) | Dietary Supplement: Prebiotin<br>* Fructo-oligosaccharide dietary supplement powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolism, Fiber, Microbiome