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Clinical Trials/NCT02217579
NCT02217579
Completed
Not Applicable

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

University of Calgary1 site in 1 country132 target enrollmentAugust 2013
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Calgary
Enrollment
132
Locations
1
Primary Endpoint
Change in baseline fat mass at 12 weeks
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
August 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Raylene Reimer

Professor

University of Calgary

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

Outcomes

Primary Outcomes

Change in baseline fat mass at 12 weeks

Time Frame: 12 weeks

Assessed with dual energy x-ray absorptiometry.

Secondary Outcomes

  • Change in baseline appetite at 12 weeks(12 weeks)

Study Sites (1)

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