Hypercholesterolemia, Cardiovascular Diseases
Conditions
Keywords
Mixed Beans
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.
Interventions
DIETARY_SUPPLEMENTCanned beans of multiple varieties
Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney
DIETARY_SUPPLEMENTWhite Rice
Minute Rice Long Grain White Rice
Sponsors
Canadian Agricultural Partnership Pulse Science Cluster Program
The Bonduelle Company (providing the canned beans)
University of Guelph
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
Countries
Canada
Outcome results
None listed