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

Study Overview
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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.

Official Title
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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

Conditions
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Hypercholesterolemia, Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Canned beans of multiple varieties
* Dietary Supplement: White Rice


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 cup of canned beans of multiple varieties<br>Consumption of 1 cup of canned beans of multiple varieties each day for 4 weeks | Dietary Supplement: Canned beans of multiple varieties<br>* Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney<br>|
| Experimental: 1/2 cup of canned beans of multiple varieties<br>Consumption of 1/2 cup of canned beans of multiple varieties each day for 4 weeks | Dietary Supplement: Canned beans of multiple varieties<br>* Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney<br>|
| Other: 1 cup of White rice<br>Consumption of 1 cup of white rice each day for 4 weeks | Dietary Supplement: White Rice<br>* Minute Rice Long Grain White Rice<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mixed Beans