Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims|
- Change in baseline fat mass at 12 weeks [ Time Frame: 12 weeks ]Assessed with dual energy x-ray absorptiometry.
- Change in baseline glucose tolerance at 12 weeks [ Time Frame: 12 weeks ]Assessed via HbA1c and an oral glucose tolerance test.
- Change in baseline appetite at 12 weeks [ Time Frame: 12 weeks ]Subjective appetite assessed with visual analog scales and objective appetite with a weighed lunch buffet.
- Change in baseline lipid profile at 12 weeks [ Time Frame: 12 weeks ]Serum lipid
- Change in baseline inflammatory markers at 12 weeks [ Time Frame: 12 weeks ]Serum cytokine
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Pulse Fibre
The intervention group will receive a biscuit containing 5g/serving of yellow pea fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.
Dietary Supplement: Pulse fibre
Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.
Placebo Comparator: Control
The placebo group will receive a biscuit an isocaloric control biscuit that is similar in taste and texture and without pulse fibre to be eaten 3 times per day approximately 30 minutes prior to their 3 largest meals.
Dietary Supplement: Control
Control biscuit with no yellow pea hull fibre.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719900
|University of Calgary|
|Calgary, Alberta, Canada, T2N 1N4|
|Principal Investigator:||Raylene Reimer, PhD, RD||University of Calgary|