Status:
COMPLETED
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
Lead Sponsor:
University of Guelph
Collaborating Sponsors:
Canadian Agricultural Partnership Pulse Science Cluster Program
The Bonduelle Company (providing the canned beans)
Conditions:
Hypercholesterolemia
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 choles...
Eligibility Criteria
Inclusion
- Male and female adults (≥18 years)
- BMI 18.5-35 kg/m2
- LDL cholesterol 3.0-5.0 mmol/L
Exclusion
- 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
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2021
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT03830970
Start Date
March 5 2019
End Date
January 5 2021
Last Update
August 5 2021
Active Locations (2)
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1
Human Nutraceutical Research Unit
Guelph, Ontario, Canada, N1G 2W1
2
Glycemic Index Laboratories, Inc
Toronto, Ontario, Canada, M5C2N8