Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults

Study Overview
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Brief Summary
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The metabolic syndrome is rising worldwide as a consequence of the continued obesity epidemic. The current obesogenic environment makes the regulation of energy intake difficult and impedes the maintenance of weight loss. Dietary patterns and/or ingredients that curb hunger and reduce energy intake are critically needed. We hypothesize that inclusion of protein and prebiotic fiber in the diet will reduce adiposity in overweight and obesity adults.

Detailed Description
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The main objective of our study is to assess the effects of protein and prebiotic fiber intake on changes in adiposity in an overweight and obese adult population. Primary objective - To determine the effect of 12 week protein (10 g/day) or prebiotic fiber (16 g/day) intake on changes in body composition, chiefly body fat. Secondary objective - To measure changes in appetite following 12 weeks of protein (10 g/day) or prebiotic fiber (16 g/day) intake. Other outcomes includes changes in quality of life ratings and gut microbiota.

Official Title
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Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Protein
* Dietary Supplement: Prebiotic fiber
* Dietary Supplement: Protein plus prebiotic fiber
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females Age 18 - 70 years BMI 25 - 38 kg/m-2 Stable body weight for at least 3 months prior to the study Exclusion Criteria: Type 1 diabetes Clinically significant cardiovascular, liver or pancreas disease Major gastrointestinal surgeries Pregnant or lactating Concomitant use of any weight loss medication, diet or exercise regime Antibiotic use in the preceding 3 months to enrollment Weight loss > 3 kg within preceding 3 months to enrollment Use of bulk laxatives, fiber supplements or probiotic/prebiotic supplements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Isocaloric food without the test protein and prebiotic fiber. | Dietary Supplement: Control<br>* An isocaloric food not containing the test protein and fiber.<br>|
| Experimental: Protein<br>Dietary protein consumed as two daily servings of 5 grams protein/serving. | Dietary Supplement: Protein<br>* A food containing 5 grams/serving of supplemental protein.<br>|
| Experimental: Fiber<br>Prebiotic fiber consumed as two daily servings of 8 grams protein/serving. | Dietary Supplement: Prebiotic fiber<br>* A food containing 8 grams/serving of supplemental prebiotic fiber.<br>|
| Experimental: Protein plus prebiotic fiber<br>Protein and prebiotic fiber consumed as two daily servings of 5 grams protein/serving plus 8 grams fiber/serving. | Dietary Supplement: Protein plus prebiotic fiber<br>* A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline fat mass at 12 weeks | Assessed with dual energy x-ray absorptiometry. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline appetite at 12 weeks | Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Appetite, Overweight, Obesity, Dietary fiber, Dietary protein