U of A/ U of M Beans and Peas Health Claim Project
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|ClinicalTrials.gov Identifier: NCT01661543|
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : December 24, 2015
The purpose of this study is to compare how regularly eating (dried) beans or peas or rice (control) lowers blood lipids, particularly Low Density Lipoprotein cholesterol and total cholesterol, in mildly hypercholesterolemic men and women. The investigators hypothesize that regularly eating beans or peas will significantly improve blood lipid profiles in these people.
Participants in this study will consume 1 study food item 5 out of 7 days a week containing beans or peas or rice for a total of 6 weeks. This study will benefit Canadian pulse growers by enhancing development of food products for human consumption and supporting marketing strategies to increase awareness that a diet rich in pulses can improve human health. Measuring changes in blood and urinary polyphenol levels will help to verify whether these compounds play a role in the beneficial actions of beans and peas and subsequently assist with the identification of the beneficial bean/pea components. This in turn, will enable crop breeders to select for plants that are rich in these compounds.
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Dietary Supplement: Beans Dietary Supplement: Control (rice) Dietary Supplement: Peas||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Substantiating a Health Claim for Pulses (Beans and Peas) and Cholesterol Lowering Abilities|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Bean consumption to lower cholesterol
This arm will consume 90 grams of beans per day for 5 out of 7 days for 6 weeks.
Dietary Supplement: Beans
90g of beans per day for 5 out of 7 days per week will be given to participants for 6 weeks to determine the cholesterol lowering effects of various pulses.
Placebo Comparator: Control (rice) consumed to show results
The control group will consume 90 grams of rice per day for 5 out of 7 days for 6 weeks.
Dietary Supplement: Control (rice)
90g of rice per day will be given to the control group to demonstrate the cholesterol lowering effects of the experimental group.
Experimental: Peas consumed to lower cholesterol
This arm will consume 90g of peas per day for 5 days out of each week for 6 weeks.
Dietary Supplement: Peas
90 grams of peas will be consumed 5 out of 7 days per week
- Lowering of Cholesterol [ Time Frame: 6 weeks ]Cholesterol will be tested at Baseline, 3 and 6 week interval
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): NCT01661543
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2E1|
|University of Manitoba|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Principal Investigator:||Rhonda C Bell, PhD||University of Alberta|
|Study Chair:||Linda McCargar, PhD||University of Alberta|
|Study Chair:||Cathy Chan, PhD||university|
|Study Chair:||Spencer Proctor, PhD||University of Alberta|
|Study Chair:||Jocelyn Ozga, PhD||University of Alberta|
|Study Chair:||David Wishart, PhD||University of Alberta|
|Study Chair:||Carla Taylor, PhD||University of Manitoba|
|Study Chair:||Peter Zahradka, PhD||University of Manitoba|
|Study Chair:||Michel Aliani, PhD||University of Manitoba|