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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498455
• Other study ID #: 1255329-5
• Status: Completed
• Phase: Phase 4
• Start date: September 30, 2018
• Est. completion date: February 15, 2019

Study information

• Verified date: August 2020
• Source: Baylor University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 15, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Metabolic Syndrome
• Weight Gain
• Weight Gain Trajectory

Intervention

Dietary Supplement:
• Prebiotin
Fructo-oligosaccharide dietary supplement powder

Locations

Country	Name	City	State
United States	Baylor University	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Study analysis