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

NCT04498455 — Phase 4, Completed, 11 participants, Baylor University

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Registry	NCT04498455
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	11 (Actual)
Sponsor	Baylor University (Other)
Conditions	Weight Gain Trajectory, Metabolic Syndrome
Interventions	Prebiotin (Dietary supplement)
Dates	start 2018-09-30, primary completion 2019-02-14, completion 2019-02-15, first posted 2020-08-04, last updated 2020-08-17
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Dietary Supplement: Prebiotin	Dietary Supplement: Placebo
Prebiotin	Active comparator	Dietary Supplement: Prebiotin	Dietary Supplement: Prebiotin (oligofructose enriched inulin)

Prebiotin (Dietary supplement): Fructo-oligosaccharide dietary supplement powder

+Outcome measures

Primary outcomes

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

Sex: All, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Baylor University	Waco, Texas	United States

+Investigators

LesLee Funderburk, Ph.D., Principal investigator, Baylor University