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

University of Guelph

Status: Completed

Conditions: Hypercholesterolemia; Cardiovascular Diseases

Treatments: Dietary Supplement: White Rice; Dietary Supplement: Canned beans of multiple varieties

Study type: Interventional

Funder types: Other

Identifiers

NCT03830970

REB-18-10-045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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73 participants in 3 patient groups

1 cup of canned beans of multiple varieties

Experimental group

Description:

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

Treatment:

Dietary Supplement: Canned beans of multiple varieties

1/2 cup of canned beans of multiple varieties

Experimental group

Description:

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

Treatment:

Dietary Supplement: Canned beans of multiple varieties

1 cup of White rice

Other group

Description:

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

Treatment:

Dietary Supplement: White Rice