search
Back to results

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

Primary Purpose

Hypercholesterolemia, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Canned beans of multiple varieties
White Rice
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring Mixed Beans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Human Nutraceutical Research Unit
  • Glycemic Index Laboratories, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

1 cup of canned beans of multiple varieties

1/2 cup of canned beans of multiple varieties

1 cup of White rice

Arm Description

Consumption of 1 cup of canned beans of multiple varieties each day for 4 weeks

Consumption of 1/2 cup of canned beans of multiple varieties each day for 4 weeks

Consumption of 1 cup of white rice each day for 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fasting serum total cholesterol, HDL cholesterol and triglycerides
Fasting serum glucose and insulin and HOMA-IR
Fasting glucose and insulin
Fasting serum and fecal short chain fatty acids
Fecal bile acids
Gut Microbiota

Full Information

First Posted
February 4, 2019
Last Updated
July 29, 2021
Sponsor
University of Guelph
Collaborators
Canadian Agricultural Partnership Pulse Science Cluster Program, The Bonduelle Company (providing the canned beans)
search

1. Study Identification

Unique Protocol Identification Number
NCT03830970
Brief 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
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
January 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
Collaborators
Canadian Agricultural Partnership Pulse Science Cluster Program, The Bonduelle Company (providing the canned beans)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Cardiovascular Diseases
Keywords
Mixed Beans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 cup of canned beans of multiple varieties
Arm Type
Experimental
Arm Description
Consumption of 1 cup of canned beans of multiple varieties each day for 4 weeks
Arm Title
1/2 cup of canned beans of multiple varieties
Arm Type
Experimental
Arm Description
Consumption of 1/2 cup of canned beans of multiple varieties each day for 4 weeks
Arm Title
1 cup of White rice
Arm Type
Other
Arm Description
Consumption of 1 cup of white rice each day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Canned beans of multiple varieties
Intervention Description
Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney
Intervention Type
Dietary Supplement
Intervention Name(s)
White Rice
Intervention Description
Minute Rice Long Grain White Rice
Primary Outcome Measure Information:
Title
Fasting serum LDL cholesterol
Description
Fasting serum LDL cholesterol will be compared among treatments at study day 29 using ANCOVA and including study day 1 as a covariate
Time Frame
4 weeks (28 days)
Secondary Outcome Measure Information:
Title
Fasting serum total cholesterol, HDL cholesterol and triglycerides
Time Frame
4 weeks (28 days)
Title
Fasting serum glucose and insulin and HOMA-IR
Description
Fasting glucose and insulin
Time Frame
4 weeks (28 days)
Title
Fasting serum and fecal short chain fatty acids
Time Frame
4 weeks (28 days)
Title
Fecal bile acids
Time Frame
4 weeks (28 days)
Title
Gut Microbiota
Time Frame
4 weeks (28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Human Nutraceutical Research Unit
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G 2W1
Country
Canada
Facility Name
Glycemic Index Laboratories, Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C2N8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34642756
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs