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Dose Effect of Canned Mixed Beans on Blood Cholesterol in Healthy Adults With Elevated Cholesterol

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ClinicalTrials.gov Identifier: NCT03830970
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborators:
Pulse Canada
Bonduelle Company
Information provided by (Responsible Party):
Alison Duncan, University of Guelph

Brief Summary:
The Bean Study will examine the effects of consuming varying doses of canned mixed beans on blood cholesterol levels in healthy adults with elevated blood cholesterol levels.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Cardiovascular Diseases Dietary Supplement: Canned mixed beans Dietary Supplement: White Rice Not Applicable

Detailed Description:
The Bean Study (TBS) is a a multi-centre, randomized, crossover design study which will examine the effects of consuming varying doses of canned mixed beans on fasting serum lipid profiles in hypercholesterolemic adults. In a randomized order, all participants will complete three 4-week study treatments consuming daily amounts of 1 cup canned mixed beans, ½ cup canned mixed beans and 1 cup of white rice separated by a 4-week washout period. At the start and finish of each treatment period, fasting blood will be collected and analyzed for lipids, short chain fatty acids (SCFA), alipoproteins, glucose and insulin. Fecal samples will also be collected and analyzed for bile acids, SCFA and gut microbiota. The effect of mixed bean consumption on height, body weight and blood pressure will also be examined.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Dose-response Study to Examine the Cholesterol-lowering Effects of Canned Mixed Beans
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1/2 cup canned mixed beans
Consumption of 1/2 cup of canned mixed beans everyday for 4 weeks
Dietary Supplement: Canned mixed beans
Black, navy, pinto, red and white kidney beans

Experimental: 1 cup canned mixed beans
Consumption of 1 cup of canned mixed beans everyday for 4 weeks
Dietary Supplement: Canned mixed beans
Black, navy, pinto, red and white kidney beans

Control: White Rice
Consumption of 1 cup of white rice everyday for 4 weeks
Dietary Supplement: White Rice
Minute Rice Long Grain White Rice




Primary Outcome Measures :
  1. Cholesterol Profile [ Time Frame: 4 weeks ]
    Total cholesterol, LDL cholesterol and HDL cholesterol


Secondary Outcome Measures :
  1. Glucose [ Time Frame: 4 weeks ]
    Fasting glucose

  2. Insulin [ Time Frame: 4 weeks ]
    Fasting insulin


Other Outcome Measures:
  1. Apolipoproteins (Apo) [ Time Frame: 4 weeks ]
    Apo B100 and apo AI

  2. Fecal Short Chain Fatty Acids [ Time Frame: 4 weeks ]
    Acetate, Propionate and Butyrate

  3. Fecal bile acids [ Time Frame: 4 weeks ]
  4. Gut Microbiota [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female adults (≥18 years)
  • BMI 18.5-35 kg/m2
  • Hypercholesterolemic (Blood LDL cholesterol >3.0 and <5.0 mmol/L)

Exclusion Criteria:

  • Blood 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830970


Contacts
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Contact: Alison M. Duncan, PhD, RD 519-824-4120 ext 53416 amduncan@uoguelph.ca
Contact: Katarina Doma, MSc 519-824-4120 ext 58081 kdoma@uoguelph.ca

Locations
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Canada, Ontario
Human Nutraceutical Research Unit Recruiting
Guelph, Ontario, Canada, N1G 2W1
Contact: Amy Tucker, PhD    519-824-4120 ext 54379    aborland@uoguelph.ca   
Glycemic Index Laboratories, Inc Recruiting
Toronto, Ontario, Canada, M5C2N8
Contact: Janice Campbell, MSc, CCRP    416-861-0506    jcampbell@gilabs.com   
Sponsors and Collaborators
University of Guelph
Pulse Canada
Bonduelle Company

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Responsible Party: Alison Duncan, Professor, University of Guelph
ClinicalTrials.gov Identifier: NCT03830970     History of Changes
Other Study ID Numbers: REB-18-10-045
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alison Duncan, University of Guelph:
Mixed Beans
Additional relevant MeSH terms:
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Hypercholesterolemia
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases