Effect of Canned Beans of Multiple Varieties in Daily Amounts of 1 Cup and 1/2 Cup on Serum LDL Cholesterol and Other Cardiovascular Disease Risk Biomarkers in Adults With Elevated LDL Cholesterol

NCT ID: NCT03830970

Last Updated: 2021-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-05

Study Completion Date

2021-01-05

Brief Summary

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The Bean Study will examine the effects of consuming two daily amounts of canned beans of multiple varieties on fasting serum cholesterol profile in adults with elevated LDL cholesterol.

Detailed Description

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The Bean Study (TBS) is a a multi-centre, randomized, crossover design study which will examine the effects of consuming two daily amounts of canned beans of multiple varieties on fasting serum cholesterol profile in adults with elevated LDL cholesterol. Participants will consume daily amounts of 1 cup canned beans, ½ cup of canned beans and 1 cup of white rice for 4 weeks each, separated by minimum 4-week washout periods. At the start and end of each 4-week treatment period, fasting blood samples will be collected and analyzed for lipids, glucose insulin and short chain fatty acids (SCFAs). Fecal samples will also be collected and analyzed for SCFA, bile acids and gut microbiota. Body weight and BMI will be also be measured at the start and end as well as mid-way of each treatment period. Finally 3-day food records will be completed mid-way during each treatment period.

Conditions

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Hypercholesterolemia Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1 cup of canned beans of multiple varieties

Consumption of 1 cup of canned beans of multiple varieties each day for 4 weeks

Group Type EXPERIMENTAL

Canned beans of multiple varieties

Intervention Type DIETARY_SUPPLEMENT

Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney

1/2 cup of canned beans of multiple varieties

Consumption of 1/2 cup of canned beans of multiple varieties each day for 4 weeks

Group Type EXPERIMENTAL

Canned beans of multiple varieties

Intervention Type DIETARY_SUPPLEMENT

Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney

1 cup of White rice

Consumption of 1 cup of white rice each day for 4 weeks

Group Type OTHER

White Rice

Intervention Type DIETARY_SUPPLEMENT

Minute Rice Long Grain White Rice

Interventions

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Canned beans of multiple varieties

Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney

Intervention Type DIETARY_SUPPLEMENT

White Rice

Minute Rice Long Grain White Rice

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Male and female adults (≥18 years)
* BMI 18.5-35 kg/m2
* LDL cholesterol 3.0-5.0 mmol/L

Exclusion Criteria

* Triglycerides ≥3.0 mmol/L
* Diabetes (fasting blood glucose ≥7.0 mmol/L)
* Blood pressure \>140/90 mmHg
* Major medical conditions
* Medical or surgical events requiring hospitalization within the last 3 months
* Medication use that would interfere with the study outcomes (e.g. cholesterol-lowering medications, diabetes-related medications, steroids). All other medications are okay if at a stable (3-month) dose
* Antibiotic use within the last 3 months
* Tobacco product use (\>5 times per week)
* Cannabis use during the study
* Probiotic supplement use (could do a 1-month washout before study)
* Dietary fibre supplement use (could do a 1-month washout before study)
* NHPs used for cholesterol lowering or glycemic control. All other NHPs are okay if at a stable (3-month) dose.
* Pulse consumption \>4 servings per week
* Food allergy or non-food life-threatening allergy
* Pregnant or breastfeeding
* Alcohol consumption (\>14 drinks/week or \>4 drinks/sitting)
* Recent or intended significant weight loss or gain (\>4 kg in previous 3 months)
* National-level or professional athlete
* Overnight shift worker
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Agricultural Partnership Pulse Science Cluster Program

UNKNOWN

Sponsor Role collaborator

The Bonduelle Company (providing the canned beans)

UNKNOWN

Sponsor Role collaborator

University of Guelph

OTHER

Sponsor Role lead

Responsible Party

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Alison Duncan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Human Nutraceutical Research Unit

Guelph, Ontario, Canada

Site Status

Glycemic Index Laboratories, Inc

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Doma KM, Dolinar KF, Dan Ramdath D, Wolever TMS, Duncan AM. Canned Beans Decrease Serum Total and LDL Cholesterol in Adults with Elevated LDL Cholesterol in a 4-wk Multicenter, Randomized, Crossover Study. J Nutr. 2021 Dec 3;151(12):3701-3709. doi: 10.1093/jn/nxab323.

Reference Type DERIVED
PMID: 34642756 (View on PubMed)

Other Identifiers

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REB-18-10-045

Identifier Type: -

Identifier Source: org_study_id

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