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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Control; Dietary supplement: Protein; Dietary supplement: Prebiotic fiber; Dietary supplement: Protein plus prebiotic fiber

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 Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Isocaloric food without the test protein and prebiotic fiber.	Dietary supplement: Control; An isocaloric food not containing the test protein and fiber.
Experimental: Protein; Dietary protein consumed as two daily servings of 5 grams protein/serving.	Dietary supplement: Protein; A food containing 5 grams/serving of supplemental protein.
Experimental: Fiber; Prebiotic fiber consumed as two daily servings of 8 grams protein/serving.	Dietary supplement: Prebiotic fiber; A food containing 8 grams/serving of supplemental prebiotic fiber.
Experimental: Protein plus prebiotic fiber; Protein and prebiotic fiber consumed as two daily servings of 5 grams protein/serving plus 8 grams fiber/serving.	Dietary supplement: Protein plus prebiotic fiber; A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in baseline fat mass at 12 weeks	Assessed with dual energy x-ray absorptiometry.	12 weeks

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	12 weeks

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: General Mills
• Investigators: Principal Investigator: Raylene A Reimer, PhD, RD, University of Calgary

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Weight loss; Appetite; Dietary protein; Dietary fiber
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: UofC Protocol REB13-0169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No