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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830970
• Other study ID #: REB-18-10-045
• Status: Completed
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: January 5, 2021

Study information

• Verified date: July 2021
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 5, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypercholesterolemia

Intervention

Dietary Supplement:
• Canned beans of multiple varieties
Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney
• White Rice
Minute Rice Long Grain White Rice

Locations

Country	Name	City	State
Canada	Human Nutraceutical Research Unit	Guelph	Ontario
Canada	Glycemic Index Laboratories, Inc	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
University of Guelph	Canadian Agricultural Partnership Pulse Science Cluster Program, The Bonduelle Company (providing the canned beans)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fasting serum total cholesterol, HDL cholesterol and triglycerides		4 weeks (28 days)
Secondary	Fasting serum glucose and insulin and HOMA-IR	Fasting glucose and insulin	4 weeks (28 days)
Secondary	Fasting serum and fecal short chain fatty acids		4 weeks (28 days)
Secondary	Fecal bile acids		4 weeks (28 days)
Secondary	Gut Microbiota		4 weeks (28 days)