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| Name | Class |
|---|---|
| General Mills | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Isocaloric food without the test protein and prebiotic fiber. |
|
| Protein | Experimental | Dietary protein consumed as two daily servings of 5 grams protein/serving. |
|
| Fiber | Experimental | Prebiotic fiber consumed as two daily servings of 8 grams protein/serving. |
|
| Protein plus prebiotic fiber | Experimental | Protein and prebiotic fiber consumed as two daily servings of 5 grams protein/serving plus 8 grams fiber/serving. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein | Dietary Supplement | A food containing 5 grams/serving of supplemental protein. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline fat mass at 12 weeks | Assessed with dual energy x-ray absorptiometry. | 12 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline quality of life rating at 12 weeks | Measured with SF-36 questionnaire | 12 weeks |
| Change in baseline gut microbiota at 12 weeks | Measured by high throughput sequencing |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raylene A Reimer, PhD, RD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28730743 | Result | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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| Prebiotic fiber |
| Dietary Supplement |
A food containing 8 grams/serving of supplemental prebiotic fiber. |
|
| Protein plus prebiotic fiber | Dietary Supplement | A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving). |
|
| Control | Dietary Supplement | An isocaloric food not containing the test protein and fiber. |
|
| 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |