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

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Cardiovascular Diseases
• Interventions: Dietary Supplement: Canned beans of multiple varieties; Dietary Supplement: White Rice

• Registration Number: NCT03830970
• Lead Sponsor: University of Guelph

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Study Start: 2019-03-05
• Primary Completion: 2021-01-05
• Study Completion: 2021-01-05
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1 cup of canned beans of multiple varieties	Canned beans of multiple varieties	Consumption of 1 cup of canned beans of multiple varieties each day for 4 weeks
1/2 cup of canned beans of multiple varieties	Canned beans of multiple varieties	Consumption of 1/2 cup of canned beans of multiple varieties each day for 4 weeks
1 cup of White rice	White Rice	Consumption of 1 cup of white rice each day for 4 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fasting serum total cholesterol, HDL cholesterol and triglycerides	4 weeks (28 days)
Fasting serum glucose and insulin and HOMA-IR	4 weeks (28 days)	Fasting glucose and insulin
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)

Trial Locations

Locations (2)

Human Nutraceutical Research Unit; 🇨🇦 Guelph, Ontario, Canada

Glycemic Index Laboratories, Inc; 🇨🇦 Toronto, Ontario, Canada