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Completed

NCT Number: NCT03830970

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutraceutical Research Unit, Guelph, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canned beans of multiple varieties

Dietary Supplement

Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney

White Rice

Dietary Supplement

Minute Rice Long Grain White Rice

Primary outcomes

  1. Fasting serum LDL cholesterol

    Time frame: 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 outcomes

  1. Fasting serum total cholesterol, HDL cholesterol and triglycerides

    Time frame: 4 weeks (28 days)

  2. Fasting serum glucose and insulin and HOMA-IR

    Time frame: 4 weeks (28 days)

    Fasting glucose and insulin

  3. Fasting serum and fecal short chain fatty acids

    Time frame: 4 weeks (28 days)

  4. Fecal bile acids

    Time frame: 4 weeks (28 days)

  5. Gut Microbiota

    Time frame: 4 weeks (28 days)

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

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

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2019
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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