Metabolic Syndrome, Weight Gain Trajectory
Conditions
Keywords
Fiber, Microbiome, Metabolism
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.
Interventions
DIETARY_SUPPLEMENTPrebiotin
Fructo-oligosaccharide dietary supplement powder
Sponsors
Baylor University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Randomized placebo-controlled trial of a fiber supplement \[Prebiotin\] compared to placebo \[maltodextrin\]
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | 12 weeks | 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. |
Countries
United States
Outcome results
None listed