Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
This trial is active, not recruiting.
|Treatments||protein, prebiotic fiber, protein plus prebiotic fiber, control|
|Sponsor||University of Calgary|
|Collaborator||General Mills Inc.|
|Start date||August 2013|
|End date||December 2014|
|Trial size||132 participants|
|Trial identifier||NCT02217579, UofC Protocol REB13-0169|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
Change in baseline fat mass at 12 weeks
time frame: 12 weeks
Change in baseline appetite at 12 weeks
time frame: 12 weeks
Male or female participants from 18 years up to 70 years old.
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
|Official title||Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults|
|Principal investigator||Raylene A Reimer, PhD, RD|
|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.|
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