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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-02-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Weight Gain Trajectory Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Dietary Supplement: Placebo

Group Type PLACEBO_COMPARATOR

Prebiotin

Intervention Type DIETARY_SUPPLEMENT

Fructo-oligosaccharide dietary supplement powder

Prebiotin

Dietary Supplement: Prebiotin (oligofructose enriched inulin)

Group Type ACTIVE_COMPARATOR

Prebiotin

Intervention Type DIETARY_SUPPLEMENT

Fructo-oligosaccharide dietary supplement powder

Interventions

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Prebiotin

Fructo-oligosaccharide dietary supplement powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes