Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome
- Conditions
- Obesity
- Registration Number
- NCT01719900
- Lead Sponsor
- University of Calgary
- Brief Summary
The recent dramatic increase in obesity has been linked to a reduction of dietary fibre intake. We hypothesized that supplementing the diet of overweight and obesity adults with pulse fibre will improve their metabolic status, chiefly defined as greater weight loss. Other metabolic health improvements may include improved glucose control and reduced inflammatory markers.
- Detailed Description
The main objective of our study is to assess the effects of pulse fibre supplementation on weight loss in an overweight and obese adult population.
Primary objective - To determine the effects of a 12 week intake of 15g/day of pea hull fibre on weight loss supported by body composition measures.
Secondary objective - To measure glucose control and appetite regulation in overweight and obese adults consuming 15g/day of pea hull fibre compared to a placebo control with the use of plasma HbA1c and an oral glucose tolerance test (OGTT).
Tertiary objective - To examine mechanisms of action of pulse fibre supplementation by determining the impact of pulse fibre supplementation on gut microbiota, serum metabolomics and fecal short-chain fatty acid and bile acid concentrations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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
- Concomitant use of any weight loss medication, diet or exercise regime
- Use of corticosteroids, anti-depressants, anti-epileptic medications, lipid lowering medication, diabetes medications
- Previous bariatric or other intestinal surgeries
- Pregnancy or lactation
- Weight loss > 3 kg within preceding 3 months to enrollment
- Use of bulk laxatives or probiotics/prebiotics supplements
- Antibiotic use in the past month
- Clinically significant cardiovascular or respiratory or liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Fat Mass at 12 Weeks Value at 12 weeks minus value at baseline Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.
- Secondary Outcome Measures
Name Time Method HbA1c at 12 Weeks 12 weeks Assessed via HbA1c
Change in Objective Appetite at 12 Weeks 12 weeks minus baseline Value at 12 weeks minus baseline energy intake during weighed lunch buffet.
Trial Locations
- Locations (1)
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of Calgary🇨🇦Calgary, Alberta, Canada