Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Control Isocaloric food without the test protein and prebiotic fiber. |
Dietary Supplement: Control
An isocaloric food not containing the test protein and fiber.
|
| Experimental: Protein Dietary protein consumed as two daily servings of 5 grams protein/serving. |
Dietary Supplement: Protein
A food containing 5 grams/serving of supplemental protein.
|
| Experimental: Fiber Prebiotic fiber consumed as two daily servings of 8 grams protein/serving. |
Dietary Supplement: Prebiotic fiber
A food containing 8 grams/serving of supplemental prebiotic fiber.
|
| Experimental: Protein plus prebiotic fiber 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
A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).
|
Outcome Measures
Primary Outcome Measures
- Change in baseline fat mass at 12 weeks [12 weeks]
Assessed with dual energy x-ray absorptiometry.
Secondary Outcome Measures
- Change in baseline appetite at 12 weeks [12 weeks]
Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet.
Other Outcome Measures
- Change in baseline quality of life rating at 12 weeks [12 weeks]
Measured with SF-36 questionnaire
- Change in baseline gut microbiota at 12 weeks [12 weeks]
Measured by high throughput sequencing
Eligibility Criteria
Criteria
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:
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Type 1 diabetes
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Clinically significant cardiovascular, liver or pancreas disease
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Major gastrointestinal surgeries
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Pregnant or lactating
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Concomitant use of any weight loss medication, diet or exercise regime
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Antibiotic use in the preceding 3 months to enrollment
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Weight loss > 3 kg within preceding 3 months to enrollment
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Use of bulk laxatives, fiber supplements or probiotic/prebiotic supplements
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Calgary | Calgary | Alberta | Canada | T2N 1N4 |
Sponsors and Collaborators
- University of Calgary
- General Mills
Investigators
- Principal Investigator: Raylene A Reimer, PhD, RD, University of Calgary
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UofC Protocol REB13-0169