Clinical trial NCT03830970: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Cardiovascular Diseases
Keywords: Mixed Beans
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: Canadian Agricultural Partnership Pulse Science Cluster Program
name: The Bonduelle Company (providing the canned beans)
First posted: 2019-02-05
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting serum LDL cholesterol
timeFrame: 4 weeks (28 days)
Secondary outcomes:
measure: Fasting serum total cholesterol, HDL cholesterol and triglycerides
timeFrame: 4 weeks (28 days)
measure: Fasting serum glucose and insulin and HOMA-IR
timeFrame: 4 weeks (28 days)
measure: Fasting serum and fecal short chain fatty acids
timeFrame: 4 weeks (28 days)
measure: Fecal bile acids
timeFrame: 4 weeks (28 days)
measure: Gut Microbiota
timeFrame: 4 weeks (28 days)
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Human Nutraceutical Research Unit
state: Ontario
city: Toronto
country: Canada
facility: Glycemic Index Laboratories, Inc
state: Ontario
Study officials:
References:
citation: 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.