Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
NCT ID: NCT02217579
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2013-08-31
2017-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control
Isocaloric food without the test protein and prebiotic fiber.
Control
An isocaloric food not containing the test protein and fiber.
Protein
Dietary protein consumed as two daily servings of 5 grams protein/serving.
Protein
A food containing 5 grams/serving of supplemental protein.
Fiber
Prebiotic fiber consumed as two daily servings of 8 grams protein/serving.
Prebiotic fiber
A food containing 8 grams/serving of supplemental prebiotic fiber.
Protein plus prebiotic fiber
Protein and prebiotic fiber consumed as two daily servings of 5 grams protein/serving plus 8 grams fiber/serving.
Protein plus prebiotic fiber
A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).
Interventions
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Protein
A food containing 5 grams/serving of supplemental protein.
Prebiotic fiber
A food containing 8 grams/serving of supplemental prebiotic fiber.
Protein plus prebiotic fiber
A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).
Control
An isocaloric food not containing the test protein and fiber.
Eligibility Criteria
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Inclusion Criteria
* Age 18 - 70 years
* BMI 25 - 38 kg/m-2
* Stable body weight for at least 3 months prior to the study
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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General Mills
INDUSTRY
University of Calgary
OTHER
Responsible Party
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Dr. Raylene Reimer
Professor
Principal Investigators
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Raylene A Reimer, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of Calgary
Calgary, Alberta, Canada
Countries
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References
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Reimer RA, Willis HJ, Tunnicliffe JM, Park H, Madsen KL, Soto-Vaca A. Inulin-type fructans and whey protein both modulate appetite but only fructans alter gut microbiota in adults with overweight/obesity: A randomized controlled trial. Mol Nutr Food Res. 2017 Nov;61(11). doi: 10.1002/mnfr.201700484. Epub 2017 Aug 29.
Other Identifiers
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UofC Protocol REB13-0169
Identifier Type: -
Identifier Source: org_study_id