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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: Canned beans of multiple varieties; Dietary supplement: White Rice

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Guelph, Ontario, Canada, N1G 2W1
      • Human Nutraceutical Research Unit
    • Toronto, Ontario, Canada, M5C2N8
      • Glycemic Index Laboratories, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 cup of canned beans of multiple varieties; Consumption of 1 cup of canned beans of multiple varieties each day for 4 weeks	Dietary supplement: Canned beans of multiple varieties; Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney
Experimental: 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	Dietary supplement: Canned beans of multiple varieties; Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney
Other: 1 cup of White rice; Consumption of 1 cup of white rice each day for 4 weeks	Dietary supplement: White Rice; Minute Rice Long Grain White Rice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting serum LDL cholesterol	Fasting serum LDL cholesterol will be compared among treatments at study day 29 using ANCOVA and including study day 1 as a covariate	4 weeks (28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting serum total cholesterol, HDL cholesterol and triglycerides		4 weeks (28 days)
Fasting serum glucose and insulin and HOMA-IR	Fasting glucose and insulin	4 weeks (28 days)
Fasting serum and fecal short chain fatty acids		4 weeks (28 days)
Fecal bile acids		4 weeks (28 days)
Gut Microbiota		4 weeks (28 days)

Collaborators and Investigators

• Sponsor: University of Guelph
• Collaborators: Canadian Agricultural Partnership Pulse Science Cluster Program; The Bonduelle Company (providing the canned beans)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Actual): January 5, 2021
• Study Completion (Actual): January 5, 2021

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Mixed Beans
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Cardiovascular Diseases; Hypercholesterolemia
• Other Study ID Numbers: REB-18-10-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No