Effect of Protein and Prebiotic Fiber Intake on Adiposity in Overweight and Obese Adults

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: Protein; Dietary Supplement: Prebiotic fiber; Dietary Supplement: Protein plus prebiotic fiber; Dietary Supplement: Control

• Registration Number: NCT02217579
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Primary Completion: 2014-12
• Study Completion: 2017-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protein	Protein	Dietary protein consumed as two daily servings of 5 grams protein/serving.
Fiber	Prebiotic fiber	Prebiotic fiber consumed as two daily servings of 8 grams protein/serving.
Protein plus 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.
Control	Control	Isocaloric food without the test protein and prebiotic fiber.

Primary Outcome Measures

Name	Time	Method
Change in baseline fat mass at 12 weeks	12 weeks	Assessed with dual energy x-ray absorptiometry.

Secondary Outcome Measures

Name	Time	Method
Change in baseline appetite at 12 weeks	12 weeks	Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet.

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada