HypercholesterolemiaNCT03830970
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
A study testing Canned beans of multiple varieties and White Rice in people with Hypercholesterolemia and Cardiovascular Diseases, run by University of Guelph at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Cardiovascular Diseases
- What is being tested?
- Canned beans of multiple varieties and White Rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Mar 2019to 5 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female adults (≥18 years)
- BMI 18.5-35 kg/m2
- LDL cholesterol 3.0-5.0 mmol/L
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Human Nutraceutical Research Unit
Guelph, Ontario, N1G 2W1
Glycemic Index Laboratories, Inc
Toronto, Ontario, M5C2N8
About this study
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.
Read the 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.
- Conditions
- Hypercholesterolemia, Cardiovascular Diseases
- Being tested
- Canned beans of multiple varieties, White Rice
- Keywords
- Mixed Beans
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canned beans of multiple varietiesDietary supplement
Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney
White RiceDietary supplement
Minute Rice Long Grain White Rice
| Study group | Role | What they receive |
|---|---|---|
| 1 cup of canned beans of multiple varieties | Experimental | Consumption of 1 cup of canned beans of multiple varieties each day for 4 weeks Receives: 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 Receives: 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 Receives: Dietary Supplement: White Rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks (28 days)
Secondary outcomes (5)
Fasting serum total cholesterol, HDL cholesterol and triglycerides
Measured: 4 weeks (28 days)
Fasting serum glucose and insulin and HOMA-IR
Fasting glucose and insulin
Measured: 4 weeks (28 days)
Fasting serum and fecal short chain fatty acids
Measured: 4 weeks (28 days)
Fecal bile acids
Measured: 4 weeks (28 days)
Gut Microbiota
Measured: 4 weeks (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start5 Mar 2019
- Primary completion5 Jan 2021
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Agricultural Partnership Pulse Science Cluster Program, The Bonduelle Company (providing the canned beans)
- Responsible party
- Principal investigator, Alison Duncan, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830970
- Sponsor's protocol ID
- REB-18-10-045
- Status last verified
- Jul 2021
- First submitted
- 4 Feb 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34642756
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03830970
- Acronym / sponsor ID
- REB-18-10-045
- Conditions
- Hypercholesterolemia, Cardiovascular Diseases
- Keywords
- Mixed Beans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Canadian Agricultural Partnership Pulse Science Cluster Program, The Bonduelle Company (providing the canned beans)
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 5 Jan 2021 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 cup of canned beans of multiple varieties | Experimental | Dietary Supplement: Canned beans of multiple varietiesConsumption of 1 cup of canned beans of multiple varieties each day for 4 weeks |
| 1/2 cup of canned beans of multiple varieties | Experimental | Dietary Supplement: Canned beans of multiple varietiesConsumption of 1/2 cup of canned beans of multiple varieties each day for 4 weeks |
| 1 cup of White rice | Other | Dietary Supplement: White RiceConsumption of 1 cup of white rice each day for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female adults (≥18 years)
- BMI 18.5-35 kg/m2
- LDL cholesterol 3.0-5.0 mmol/L
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canned beans of multiple varietiesDaily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney | Dietary supplement | 1 cup of canned beans of multiple varieties, 1/2 cup of canned beans of multiple varieties |
| White RiceMinute Rice Long Grain White Rice | Dietary supplement | 1 cup of White rice |
Primary outcome
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
5 secondary outcomes
Fasting serum total cholesterol, HDL cholesterol and triglycerides
Time frame: 4 weeks (28 days)
Fasting serum glucose and insulin and HOMA-IR
Time frame: 4 weeks (28 days)
Fasting serum and fecal short chain fatty acids
Time frame: 4 weeks (28 days)
Fecal bile acids
Time frame: 4 weeks (28 days)
Gut Microbiota
Time frame: 4 weeks (28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Derived from this study: PubMed 34642756Doma 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canned beans of multiple varieties and White Rice in people with Hypercholesterolemia and Cardiovascular Diseases, run by University of Guelph at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting serum LDL cholesterol (time frame: 4 weeks (28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.