Clinical trial NCT02217579: Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
Official title: Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight loss
Appetite
Overweight
Obesity
Dietary fiber
Dietary protein
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: General Mills
First posted: 2014-08-15
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Change in baseline fat mass at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in baseline appetite at 12 weeks
timeFrame: 12 weeks
Other outcomes:
measure: Change in baseline quality of life rating at 12 weeks
timeFrame: 12 weeks
measure: Change in baseline gut microbiota at 12 weeks
timeFrame: 12 weeks
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Raylene A Reimer, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.