NCT03830970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

March 5, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2021

Completed
Last Updated

August 5, 2021

Status Verified

July 1, 2021

Enrollment Period

1.8 years

First QC Date

February 4, 2019

Last Update Submit

July 29, 2021

Conditions

HypercholesterolemiaCardiovascular Diseases

Keywords

Mixed Beans

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Fasting serum total cholesterol, HDL cholesterol and triglycerides

    4 weeks (28 days)

  • Fasting serum glucose and insulin and HOMA-IR

    4 weeks (28 days)

  • Fasting serum and fecal short chain fatty acids

    4 weeks (28 days)

  • Fecal bile acids

    4 weeks (28 days)

  • Gut Microbiota

    4 weeks (28 days)

Study Arms (3)

1 cup of canned beans of multiple varieties

EXPERIMENTAL

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

Dietary Supplement: Canned beans of multiple varieties

1/2 cup of canned beans of multiple varieties

EXPERIMENTAL

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

Dietary Supplement: Canned beans of multiple varieties

1 cup of White rice

OTHER

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

Dietary Supplement: White Rice

Interventions

Canned beans of multiple varietiesDIETARY_SUPPLEMENT

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

1 cup of canned beans of multiple varieties1/2 cup of canned beans of multiple varieties
White RiceDIETARY_SUPPLEMENT

Minute Rice Long Grain White Rice

1 cup of White rice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Human Nutraceutical Research Unit

Guelph, Ontario, N1G 2W1, Canada

Location

Glycemic Index Laboratories, Inc

Toronto, Ontario, M5C2N8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 34642756DERIVED

MeSH Terms

Conditions

HypercholesterolemiaCardiovascular Diseases

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 5, 2019

Study Start

March 5, 2019

Primary Completion

January 5, 2021

Study Completion

January 5, 2021

Last Updated

August 5, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)