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OpenTrials
Completed

NCT Number: NCT04498455

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

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.

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Key information

Conditions

Weight Gain Trajectory Body Weight Body Weight Changes Body-Weight Trajectory Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baylor University

Waco, Texas, 76798, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prebiotin

Dietary Supplement

Fructo-oligosaccharide dietary supplement powder

Primary outcomes

  1. Change in body weight

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Baylor University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 4, 2020
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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