Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome
|ClinicalTrials.gov Identifier: NCT01719900|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Dietary Supplement: Pulse fibre Dietary Supplement: Control||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of Pulse Fibre Supplementation in Obesity and the Metabolic Syndrome: Generating Evidence in Support of Health Claims|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||December 2018|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719900
|University of Calgary|
|Calgary, Alberta, Canada, T2N 1N4|
|Principal Investigator:||Raylene Reimer, PhD, RD||University of Calgary|