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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Dietary Supplement: Placebo |
|
| Prebiotin | Active Comparator | Dietary Supplement: Prebiotin (oligofructose enriched inulin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotin | Dietary Supplement | Fructo-oligosaccharide dietary supplement powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LesLee Funderburk, Ph.D. | Baylor University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University | Waco | Texas | 76798 | United States |
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| Label | URL |
|---|---|
| Study analysis | View source |
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No plan to share individual data
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| ID | Term |
|---|---|
| D000077962 | Body-Weight Trajectory |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized placebo-controlled trial of a fiber supplement [Prebiotin] compared to placebo [maltodextrin]
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| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |