Evaluation of Pulse Fibre Supplementation on Obesity and the Metabolic Syndrome
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|ClinicalTrials.gov Identifier: NCT01719900|
Recruitment Status : Completed
First Posted : November 1, 2012
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
|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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 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|
|Actual Study Completion Date :||November 26, 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 Fat Mass at 12 Weeks [ Time Frame: Value at 12 weeks minus value at baseline ]Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.
- HbA1c at 12 Weeks [ Time Frame: 12 weeks ]Assessed via HbA1c
- Change in Objective Appetite at 12 Weeks [ Time Frame: 12 weeks minus baseline ]Value at 12 weeks minus baseline energy intake during weighed lunch buffet.
- Cholesterol Profile at 12 Weeks [ Time Frame: 12 weeks ]Serum LDL (low density lipoprotein) cholesterol
- Serum Cytokine at 12 Weeks [ Time Frame: 12 weeks ]Serum cytokine IL-6 measured at 12 weeks
- Alpha Diversity of Gut Microbiota at 12 Weeks [ Time Frame: 12 weeks ]Gut microbiota alpha diversity measured at 12 weeks as Chao index. Chao index is an abundance-based estimator of species richness within a sample. There are no preset minimum and maximum values but scores typically range from 0 to 4000. A higher score is generally regarded as better.
- Serum Metabolomics at 12 Weeks [ Time Frame: 12 weeks ]Serum metabolomics measured at 12 weeks using 1H-NMR analysis. Principal component analysis is used to see if two or more groups of samples separate into distinct clusters. The principal components generated in this analysis range from 0-100%. A higher value means that more variability among the samples is explained by this principal component.
- Fecal Short-chain Fatty Acid Concentrations [ Time Frame: 12 weeks ]Fecal acetate concentration measured at 12 weeks
- Fecal Bile Acid Concentration [ Time Frame: 12 weeks ]Fecal cholic acid concentration measured at 12 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|