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

NCT04498455 | Completed Phase 4

• 1 other identifier: 1255329-5
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Gain Trajectory; Metabolic Syndrome

Keywords

Fiber; Microbiome; Metabolism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Dietary Supplement: Prebiotin

Prebiotin

ACTIVE COMPARATOR

Dietary Supplement: Prebiotin (oligofructose enriched inulin)

Dietary Supplement: Prebiotin

Interventions

Prebiotin DIETARY_SUPPLEMENT

Fructo-oligosaccharide dietary supplement powder

Placebo; Prebiotin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently a resident in training at the Family Health Center in their first year.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor University: lead

Study Sites (1)

Baylor University

Waco, Texas, 76798, United States

Location

Related Links

• Study analysis

MeSH Terms

Conditions

Body-Weight Trajectory; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• LesLee Funderburk, Ph.D.

  Baylor University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nutrition Sciences

Model Details: Randomized placebo-controlled trial of a fiber supplement \[Prebiotin\] compared to placebo \[maltodextrin\]

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 4, 2020
• Study Start: September 30, 2018
• Primary Completion: February 14, 2019
• Study Completion: February 15, 2019
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)