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
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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||20 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Male, or non-pregnant, non-lactating females, aged 20 to 75 years; This age range allows for a large variety of participants.
- LDL-cholesterol >3.00 mmol/L and <5.00 mmol/L; Cholesterol is high enough that a lowering can be seen, but low enough that the participant is not taking medications or alternative measures to lower cholesterol.
- Fasting triglycerides <4.00 mmol/L; Low enough that it is not dangerous to participant, but high enough to see a lowering effect.
- Stable body weight (±5%) for the past 3 months and BMI of 20-40; Participants with high BMI are more likely to have high lipid levels, it is important to have a stable body weight so energy requirements are not drastically changing during the study period.
- Must be on a stable regime for the past 3 months if taking medications or if taking vitamin and mineral/dietary/herbal supplements; Stable regime reduces risk of any changes during study.
- Able to read, write and communicate orally in English; All questionnaires and communication will be completed in English.
Willing to comply with the protocol requirements, including a stable level of physical activity during the study and no other pulse-containing foods consumed during the study; this will ensure the most valid results.
Willing to provide informed consent.
- Regular high pulse consumption (>2 servings per week); Any additional pulse consumption will affect the outcome of the study.
- Use of medications to lower blood lipids or to lower blood glucose; the aim of the study is to prove the cholesterol lowering capabilities of beans and peas, any other methods of blood lipid lowering will skew data.
- Use of non-prescription products designed to lower blood lipids (e.g. margarine or yogurt with added plant sterols) within the past 3 months; see above
- Medical history of liver disease, renal insufficiency, inflammatory bowel disease or other gastrointestinal disorders influencing gastrointestinal motility or nutrient absorption; this will decrease effectiveness of bean/ consumption.
- Any active medical or surgical condition(s) within the past 3 months precluding study participation; participants must be in a stable condition with no recovery or pending surgery.
- Conditions or medications which are likely to increase the risk to the participants or study personnel, or to reduce the ability of the participant to comply with the protocol, or affect the results;
- History of gastrointestinal reactions or allergies to beans, peas or rice-based foods, or to one or more ingredients in the study foods which significantly limits the number of study foods that can be consumed.
- Currently participating in or having participated in a food intervention study within the last 3 months.
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|
|Responsible Party:||University of Alberta|
|Other Study ID Numbers:||
|First Posted:||August 9, 2012 Key Record Dates|
|Last Update Posted:||December 24, 2015|
|Last Verified:||December 2015|
Lipid Metabolism Disorders