NCT01661543

Brief Summary

The purpose of this study is to compare how regularly eating (dried, cooked) beans or peas or rice (control) contained in foods (such as stews or soups) lowers blood lipids, particularly Low Density Lipoprotein cholesterol (LDL-c) in adult men and women with mildly elevated LDL-c . The investigators hypothesize that regularly eating beans or peas will significantly improve LDL-c in these people. Participants in this study will consume 1 study food item, 5 out of 7 days per week containing beans or peas or rice for a total of 6 weeks. Measuring changes in blood and urinary polyphenol levels may help to verify whether these ingredients play a role in the beneficial actions attributed to regularly eating pulses. It may subsequently assist with the identification of the beneficial bean/pea components. This study will could benefit people who wish to incorporate beans and/or peas into their diet. It may also 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 LDL-c. This in turn, could enable crop breeders to select for plants that are rich in these compounds.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

2.9 years

First QC Date

August 7, 2012

Last Update Submit

August 21, 2024

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Fasting Low Density Lipoprotein-cholesterol (LDL-c) at 6 weeks

    Fasting LDL-c at 6 weeks

    6 weeks

Secondary Outcomes (14)

  • Fasting LDL-cholesterol at 3 weeks

    3 weeks

  • Fasting HDL-cholesterol

    3 and 6 weeks

  • Fasting non-HDL-cholesterol

    3 and 6 weeks

  • Fasting Total Cholesterol

    3 and 6 weeks.

  • Fasting Triglycerides

    3 and 6 weeks

  • +9 more secondary outcomes

Other Outcomes (4)

  • Dietary Intake from 3-day Food Records

    1, 3 and 6 weeks

  • Satiety

    1, 3 and 6 weeks

  • Changes in GI function

    1, 3 and 6 weeks

  • +1 more other outcomes

Study Arms (3)

Bean consumption to lower cholesterol

EXPERIMENTAL

This arm will consume 120 grams of cooked beans per day in a food item such as a soup or stew for 5 out of 7 days for 6 weeks. The bases (i.e. vegetables, broth, seasonings, etc) for all food items are the same in all groups.

Dietary Supplement: Beans

Control (rice) consumed to show results

PLACEBO COMPARATOR

The control group will consume 110 grams (\~3/4 c) of rice per day in a food item such as a soup or study for 5 out of 7 days for 6 weeks. This amount of rice is similar in volume to 120g of beans or peas. The bases (i.e. vegetables, broth, seasonings, etc) for all food items are the same in all groups.

Dietary Supplement: Control (rice)

Peas consumed to lower cholesterol

EXPERIMENTAL

This arm will consume 120 g of cooked peas per day per day in a food item such as a soup or stew for 5 days out of 7 days for 6 weeks. The bases (i.e. vegetables, broth, seasonings, etc) for all food items are the same in all groups.

Dietary Supplement: Peas

Interventions

BeansDIETARY_SUPPLEMENT

120g 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.

Bean consumption to lower cholesterol
Control (rice)DIETARY_SUPPLEMENT

110g (3/4 c) of rice per day will be given to the control group to demonstrate the cholesterol lowering effects of the experimental group. This amount of rice equates to a similar volume as 120g of cooked beans or peas.

Control (rice) consumed to show results
PeasDIETARY_SUPPLEMENT

120 grams of peas will be consumed 5 out of 7 days per week

Peas consumed to lower cholesterol

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (2)

  • Bell RC, Zahradka P, Aliani M, Liang Y, Jarman M, MacKenzie M, Chan C, Ozga J, Proctor S, Wishart D, Taylor CG. A Comparison of Dry Bean and Pea Consumption on Serum Cholesterol: A Randomized Controlled Trial in Adults with Mild Hypercholesterolemia. J Nutr. 2024 Nov;154(11):3375-3387. doi: 10.1016/j.tjnut.2024.09.011. Epub 2024 Sep 30.

    PMID: 39357673DERIVED

  • Pauls SD, Du Y, Clair L, Winter T, Aukema HM, Taylor CG, Zahradka P. Impact of Age, Menopause, and Obesity on Oxylipins Linked to Vascular Health. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):883-897. doi: 10.1161/ATVBAHA.120.315133. Epub 2020 Dec 31.

    PMID: 33380172DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

lunatusin, Phaseolus lunatus

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rhonda C Bell, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigators and data analysts were blinded to participant group assignment.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 9, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations

CA(2)