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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04498455
Other study ID # 1255329-5
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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