U of A/ U of M Beans and Peas Health Claim Project

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Alberta
Sponsor:
Collaborators:
Alberta Innovates Health Solutions
Pulse Canada
University of Manitoba
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01661543
First received: August 7, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Hypercholesterolemia
Dietary Supplement: Beans
Dietary Supplement: Control (rice)
Dietary Supplement: Peas
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Substantiating a Health Claim for Pulses (Beans and Peas) and Cholesterol Lowering Abilities

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Lowering of Cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Cholesterol will be tested at Baseline, 3 and 6 week interval


Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661543

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2E1
Contact: Janis L Baarda, BSc    780-492-4182    jbaarda@ualberta.ca   
Contact: Rhonda C Bell, PhD    780-492-7742    rhonda.bell@ualberta.ca   
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Carla Taylor, PhD    (204) 258-1361    carla.taylor@ad.umanitoba.ca   
Contact: Brendon Foot, BA    (204) 258-1207    bfoot@sbrc.ca   
Principal Investigator: Carla Taylor, PhD         
Sponsors and Collaborators
University of Alberta
Alberta Innovates Health Solutions
Pulse Canada
University of Manitoba
Investigators
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
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01661543     History of Changes
Other Study ID Numbers: QFH-11-044
Study First Received: August 7, 2012
Last Updated: April 14, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 26, 2014