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

Primary Purpose

Weight Gain Trajectory, Metabolic Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prebiotin
Sponsored by
Baylor University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Gain Trajectory focused on measuring Fiber, Microbiome, Metabolism

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Baylor University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Prebiotin

Arm Description

Dietary Supplement: Placebo

Dietary Supplement: Prebiotin (oligofructose enriched inulin)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 30, 2020
Last Updated
August 13, 2020
Sponsor
Baylor University
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1. Study Identification

Unique Protocol Identification Number
NCT04498455
Brief Title
Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency
Official Title
Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2018 (Actual)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain Trajectory, Metabolic Syndrome
Keywords
Fiber, Microbiome, Metabolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized placebo-controlled trial of a fiber supplement [Prebiotin] compared to placebo [maltodextrin]
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dietary Supplement: Placebo
Arm Title
Prebiotin
Arm Type
Active Comparator
Arm Description
Dietary Supplement: Prebiotin (oligofructose enriched inulin)
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotin
Intervention Description
Fructo-oligosaccharide dietary supplement powder
Primary Outcome Measure Information:
Title
Change in body weight
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LesLee Funderburk, Ph.D.
Organizational Affiliation
Baylor University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor University
City
Waco
State/Province
Texas
ZIP/Postal Code
76798
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual data
Links:
URL
https://greathouselab.github.io/Fiber_Intervention_Study/
Description
Study analysis

Learn more about this trial

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

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