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

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Baylor University

Status and phase

Completed
Phase 4

Conditions

Weight Gain Trajectory
Metabolic Syndrome

Treatments

Dietary Supplement: Prebiotin

Study type

Interventional

Funder types

Other

Identifiers

NCT04498455
1255329-5

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

11 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Dietary Supplement: Placebo
Treatment:
Dietary Supplement: Prebiotin
Prebiotin
Active Comparator group
Description:
Dietary Supplement: Prebiotin (oligofructose enriched inulin)
Treatment:
Dietary Supplement: Prebiotin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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