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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217579
• Other study ID #: UofC Protocol REB13-0169
• Status: Completed
• Phase: N/A
• First received: August 13, 2014
• Last updated: October 24, 2017
• Start date: August 2013
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: August 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Protein
A food containing 5 grams/serving of supplemental protein.
• Prebiotic fiber
A food containing 8 grams/serving of supplemental prebiotic fiber.
• Protein plus prebiotic fiber
A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).
• Control
An isocaloric food not containing the test protein and fiber.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	General Mills Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in baseline quality of life rating at 12 weeks	Measured with SF-36 questionnaire	12 weeks
Other	Change in baseline gut microbiota at 12 weeks	Measured by high throughput sequencing	12 weeks
Primary	Change in baseline fat mass at 12 weeks	Assessed with dual energy x-ray absorptiometry.	12 weeks
Secondary	Change in baseline appetite at 12 weeks	Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet.	12 weeks