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

• Sponsor: University of Guelph (Other)
• Overall Status: Completed
• CT.gov ID: NCT03830970
• Collaborator: Canadian Agricultural Partnership Pulse Science Cluster Program (Other), The Bonduelle Company (providing the canned beans) (Other)
• Enrollment: 73
• Locations: 2
• Arms: 3
• Actual Duration (Months): 22.1
• Patients Per Site: 36.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia; Cardiovascular Diseases	Dietary Supplement: Canned beans of multiple varieties; Dietary Supplement: White Rice	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Mar 5, 2019
• Actual Primary Completion Date: Jan 5, 2021
• Actual Study Completion Date: Jan 5, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Fasting serum total cholesterol, HDL cholesterol and triglycerides [4 weeks (28 days)]

2. Fasting serum glucose and insulin and HOMA-IR [4 weeks (28 days)]

   Fasting glucose and insulin

3. Fasting serum and fecal short chain fatty acids [4 weeks (28 days)]

4. Fecal bile acids [4 weeks (28 days)]

5. Gut Microbiota [4 weeks (28 days)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Human Nutraceutical Research Unit	Guelph	Ontario	Canada	N1G 2W1
2	Glycemic Index Laboratories, Inc	Toronto	Ontario	Canada	M5C2N8

Sponsors and Collaborators

• University of Guelph
• Canadian Agricultural Partnership Pulse Science Cluster Program
• The Bonduelle Company (providing the canned beans)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alison Duncan, Professor, University of Guelph
• ClinicalTrials.gov Identifier: NCT03830970
• Other Study ID Numbers: REB-18-10-045
• First Posted: Feb 5, 2019
• Last Update Posted: Aug 5, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alison Duncan, Professor, University of Guelph: Mixed Beans
• Additional relevant MeSH terms: Cardiovascular Diseases; Hypercholesterolemia

Study Results

No Results Posted as of Aug 5, 2021