Overview

This trial is active, not recruiting.

Condition obesity
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Isocaloric food without the test protein and prebiotic fiber.
control
An isocaloric food not containing the test protein and fiber.
(Experimental)
Dietary protein consumed as two daily servings of 5 grams protein/serving.
protein
A food containing 5 grams/serving of supplemental protein.
(Experimental)
Prebiotic fiber consumed as two daily servings of 8 grams protein/serving.
prebiotic fiber
A food containing 8 grams/serving of supplemental prebiotic fiber.
(Experimental)
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).

Primary Outcomes

Measure
Change in baseline fat mass at 12 weeks
time frame: 12 weeks

Secondary Outcomes

Measure
Change in baseline appetite at 12 weeks
time frame: 12 weeks

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Calgary.