Obesity
Conditions
Keywords
Weight loss, Appetite, Overweight, Obesity, Dietary fiber, Dietary protein
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.
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.
Interventions
DIETARY_SUPPLEMENTProtein
A food containing 5 grams/serving of supplemental protein.
DIETARY_SUPPLEMENTPrebiotic fiber
A food containing 8 grams/serving of supplemental prebiotic fiber.
DIETARY_SUPPLEMENTProtein plus prebiotic fiber
A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).
DIETARY_SUPPLEMENTControl
An isocaloric food not containing the test protein and fiber.
Sponsors
General Mills
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline fat mass at 12 weeks | 12 weeks | Assessed with dual energy x-ray absorptiometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed