HealthyBBB-2014NCT02342340

Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.

A study testing Navy Beans (cooked), Red Kidney Beans (cooked) and Pinto Beans (cooked in people with Healthy, run by Dr. Peter Zahradka at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single site, blinded, randomized, controlled study designed to examine phytochemical absorption, metabolism and excretion, as well as vascular health and satiety, after ingestion of 4 different bean varieties (pinto, navy, red kidney, black). Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Navy Beans (cooked), Red Kidney Beans (cooked) and Pinto Beans (cooked
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteCanada
Study dates: Jan 2015to Feb 2016
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 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males or females, ≥18 and ≤50 years;
Normal blood lipid profile, creatinine ≥7 units/L and ≤56 units/L, alanine aminotransferase (ALT) ≥0.7 mg/dL and ≤1.3 mg/dL for men and ≥0.6 mg/dL and ≤1.1 mg/dL for women, and glycated hemoglobin <6%;
Blood pressure <140/90
Body mass index (BMI) ≥20 and <30;
Stable regime for the past 3 months if taking vitamin and mineral/dietary/ herbal supplements;
Agree not to eat beans or bean-based foods, lentils or lentil-based foods, or consume isoflavone supplements while participating in this study;
Willing to comply with the protocol requirements;
Willing to provide informed consent.

Who cannot join

Allergies to beans, bean flour or bean products, lentils or rice;
Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
Taking any prescribed medication in the last 3 months (with the exception of birth control) or supplements that affect gastrointestinal function in the last 3 months;
Weight loss of ≥3 kg of body weight within the 6 months prior to enrolling in the study;
Current (within the last month) bacterial, viral or fungal infection, or over-the-counter medication within the past 72 hours;
Pregnant or lactating;
Unable to obtain blood samples at the screening visit or the first study visit.

Trial locations and contacts

1 site in 1 country.

Canada1 site

St.Boniface Hospital
Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

Official title: A Blinded, Randomized, Controlled Study to Examine the Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.

Read the detailed description

Recruitment will consist of a total of 8 volunteers. Volunteers will be recruited through advertisement from the local community.

The study will be conducted at the I.H. Asper Clinical Research Institute,located at the St. Boniface Hospital. Participants will be asked to provide written informed consent prior to participation in the study. Participants who have provided written consent will be asked to attend an in-patient visit to provide a fasting blood sample. Should the participant be eligible to participate, they will be scheduled for six study visits to assess the bioavailability, metabolism and excretion of phytochemicals present in beans compared to lentils and white rice.

Uptake, metabolism and excretion of phytochemicals present in different varieties of beans during acute phase testing in healthy individuals will be examined. Possible relationships between phytochemical composition of the beans, arterial function and satiety will be investigated as the secondary objective.

Conditions: Healthy
Being tested: Navy Beans (cooked), Red Kidney Beans (cooked), Pinto Beans (cooked, Black Beans (cooked), Lentils (cooked)
Keywords: Beans, Lentils, Bioavailability, Phytochemical Absorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Navy Beans (cooked)Other
One time consumption of 3/4 cup of cooked navy beans.
Red Kidney Beans (cooked)Other
One time consumption of 3/4 cup of cooked red kidney beans.
Pinto Beans (cookedOther
One time consumption of 3/4 cup of cooked pinto beans.
Black Beans (cooked)Other
One time consumption of 3/4 cup of cooked black beans.
Lentils (cooked)Other
One time consumption of 3/4 cup of cooked lentils.
White RiceOther
One time consumption of 3/4 cup of cooked white rice.

Study groups in NCT02342340
Study group	Role	What they receive
Navy Beans (cooked)	Active comparator	At one of the six visits, participants will consume a ¾ cup of cooked navy beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed. Receives: Other: Navy Beans (cooked)
Red Kidney Beans (cooked)	Active comparator	At one of the six visits, participants will consume a ¾ cup of cooked red kidney beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed. Receives: Other: Red Kidney Beans (cooked)
Pinto Beans (cooked)	Active comparator	At one of the six visits, participants will consume a ¾ cup of cooked pinto beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed. Receives: Other: Pinto Beans (cooked
Black Beans (cooked)	Active comparator	At one of the six visits, participants will consume a ¾ cup of cooked navy beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed. Receives: Other: Black Beans (cooked)
Lentils (cooked)	Active comparator	At one of the six visits, participants will consume a ¾ cup of cooked lentils. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed. Receives: Other: Lentils (cooked)
White Rice (cooked)	Placebo comparator	At one of the six visits, participants will consume a ¾ cup of cooked white rice. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed. Receives: Other: White Rice

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite measure of Absorption, Metabolism and Excretion of Phytochemicals
Blood and urine samples will be analyzed using a differential analysis for metabolites (p<0.01 and fold changes ≥ 2) which will be achieved via principle component analysis (PCA), and partial least square (PLS).
Measured: Timepoint 0 (prior to consumption), 0.5, 1.0, 1.5, 2, 4 and 6 hours post consumption

Secondary outcomes (2)

Changes in parameters of arterial stiffness through pulse wave analysis (PWA)
A measure of changes in arterial stiffness as assessed via pulse wave analysis (PWA) using a Mobil-O-Graph PWA Monitor prior to consumption, at 2 hours and 6 hours post-consumption.
Measured: Time points 0 (prior to consumption) and 2 and 6 hours post consumption.
Satiety Questionnaire
Participants will complete a Satiety Questionnaire 5 hours after consumption of the study product.
Measured: 5 hours after consumption of study product

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Feb 2016

First posted19 Jan 2015 (estimated)
Study startJan 2015
Primary completionFeb 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02342340
Sponsor's protocol ID: B2014:122
Acronym: BBB-2014
Status last verified: May 2016
First submitted: 14 Jan 2015
Last updated: 13 May 2016
Results posted: No
Data monitoring committee: No

Publications

Hanson MG, Zahradka P, Taylor CG. Lentil-based diets attenuate hypertension and large-artery remodelling in spontaneously hypertensive rats. Br J Nutr. 2014 Feb;111(4):690-8. doi: 10.1017/S0007114513002997. Epub 2013 Sep 24.
PubMed 24063808
Zahradka P, Wright B, Weighell W, Blewett H, Baldwin A, O K, Guzman RP, Taylor CG. Daily non-soy legume consumption reverses vascular impairment due to peripheral artery disease. Atherosclerosis. 2013 Oct;230(2):310-4. doi: 10.1016/j.atherosclerosis.2013.07.048. Epub 2013 Aug 6.
PubMed 24075762
Vinaixa M, Samino S, Saez I, Duran J, Guinovart JJ, Yanes O. A Guideline to Univariate Statistical Analysis for LC/MS-Based Untargeted Metabolomics-Derived Data. Metabolites. 2012 Oct 18;2(4):775-95. doi: 10.3390/metabo2040775.
PubMed 24957762
Nyamundanda G, Gormley IC, Fan Y, Gallagher WM, Brennan L. MetSizeR: selecting the optimal sample size for metabolomic studies using an analysis based approach. BMC Bioinformatics. 2013 Nov 21;14:338. doi: 10.1186/1471-2105-14-338.
PubMed 24261687

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Blinded, Randomized, Controlled Study to Examine the Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.
ClinicalTrials.gov ID: NCT02342340
Acronym / sponsor ID: BBB-2014 / B2014:122
Conditions: Healthy
Keywords: Beans, Lentils, Bioavailability, Phytochemical Absorption
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Dr. Peter ZahradkaUniversity, hospital or other
Collaborators: Manitoba Pulse Growers
Study start: Jan 2015
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 19 Jan 2015 (estimated)
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.

Detailed description

Recruitment will consist of a total of 8 volunteers. Volunteers will be recruited through advertisement from the local community.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 6

Arm	Type	Receives
Navy Beans (cooked)	Active comparator	Other: Navy Beans (cooked)At one of the six visits, participants will consume a ¾ cup of cooked navy beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.
Red Kidney Beans (cooked)	Active comparator	Other: Red Kidney Beans (cooked)At one of the six visits, participants will consume a ¾ cup of cooked red kidney beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.
Pinto Beans (cooked)	Active comparator	Other: Pinto Beans (cookedAt one of the six visits, participants will consume a ¾ cup of cooked pinto beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.
Black Beans (cooked)	Active comparator	Other: Black Beans (cooked)At one of the six visits, participants will consume a ¾ cup of cooked navy beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.
Lentils (cooked)	Active comparator	Other: Lentils (cooked)At one of the six visits, participants will consume a ¾ cup of cooked lentils. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.
White Rice (cooked)	Placebo comparator	Other: White RiceAt one of the six visits, participants will consume a ¾ cup of cooked white rice. Participants will be provided with 100 ml of water with the food, and will be allowed to drink water whenever necessary during the 6 hour test period. The participants will not be blinded to the order and the type of food product they receive at a visit, however, the samples will be assigned a number to ensure the analytical team is blinded to the test product until the end of the study. Should the need to re-administer a test product arise, the participant will receive the test product from the same treatment number again at an extra visit after the original 6 visits have been completed.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Males or females, ≥18 and ≤50 years;
Normal blood lipid profile, creatinine ≥7 units/L and ≤56 units/L, alanine aminotransferase (ALT) ≥0.7 mg/dL and ≤1.3 mg/dL for men and ≥0.6 mg/dL and ≤1.1 mg/dL for women, and glycated hemoglobin <6%;
Blood pressure <140/90
Body mass index (BMI) ≥20 and <30;
Stable regime for the past 3 months if taking vitamin and mineral/dietary/ herbal supplements;

Key exclusion criteria (7 listed)

Allergies to beans, bean flour or bean products, lentils or rice;
Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;
Taking any prescribed medication in the last 3 months (with the exception of birth control) or supplements that affect gastrointestinal function in the last 3 months;
Weight loss of ≥3 kg of body weight within the 6 months prior to enrolling in the study;
Current (within the last month) bacterial, viral or fungal infection, or over-the-counter medication within the past 72 hours;

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
Navy Beans (cooked)One time consumption of 3/4 cup of cooked navy beans.	Other	Navy Beans (cooked)
Red Kidney Beans (cooked)One time consumption of 3/4 cup of cooked red kidney beans.	Other	Red Kidney Beans (cooked)
Pinto Beans (cookedOne time consumption of 3/4 cup of cooked pinto beans.	Other	Pinto Beans (cooked)
Black Beans (cooked)One time consumption of 3/4 cup of cooked black beans.	Other	Black Beans (cooked)
Lentils (cooked)One time consumption of 3/4 cup of cooked lentils.	Other	Lentils (cooked)
White RiceOne time consumption of 3/4 cup of cooked white rice.	Other	White Rice (cooked)

Primary outcome

Composite measure of Absorption, Metabolism and Excretion of Phytochemicals
Time frame: Timepoint 0 (prior to consumption), 0.5, 1.0, 1.5, 2, 4 and 6 hours post consumption
Blood and urine samples will be analyzed using a differential analysis for metabolites (p<0.01 and fold changes ≥ 2) which will be achieved via principle component analysis (PCA), and partial least square (PLS).

2 secondary outcomes

Changes in parameters of arterial stiffness through pulse wave analysis (PWA)
Time frame: Time points 0 (prior to consumption) and 2 and 6 hours post consumption.
Satiety Questionnaire
Time frame: 5 hours after consumption of study product

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 13 May 2016.
Background: PubMed 24063808Hanson MG, Zahradka P, Taylor CG. Lentil-based diets attenuate hypertension and large-artery remodelling in spontaneously hypertensive rats. Br J Nutr. 2014 Feb;111(4):690-8. doi: 10.1017/S0007114513002997. Epub 2013 Sep 24.
Background: PubMed 24075762Zahradka P, Wright B, Weighell W, Blewett H, Baldwin A, O K, Guzman RP, Taylor CG. Daily non-soy legume consumption reverses vascular impairment due to peripheral artery disease. Atherosclerosis. 2013 Oct;230(2):310-4. doi: 10.1016/j.atherosclerosis.2013.07.048. Epub 2013 Aug 6.
Background: PubMed 24957762Vinaixa M, Samino S, Saez I, Duran J, Guinovart JJ, Yanes O. A Guideline to Univariate Statistical Analysis for LC/MS-Based Untargeted Metabolomics-Derived Data. Metabolites. 2012 Oct 18;2(4):775-95. doi: 10.3390/metabo2040775.
Background: PubMed 24261687Nyamundanda G, Gormley IC, Fan Y, Gallagher WM, Brennan L. MetSizeR: selecting the optimal sample size for metabolomic studies using an analysis based approach. BMC Bioinformatics. 2013 Nov 21;14:338. doi: 10.1186/1471-2105-14-338.
Canadian Centre for Agri-Food Research in Health and MedicineLink provided by the sponsor.

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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.

Peter Zahradka, PhD principal investigator

University of Manitoba

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Navy Beans (cooked), Red Kidney Beans (cooked) and Pinto Beans (cooked in people with Healthy, run by Dr. Peter Zahradka at 1 site 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 8 inclusion and 7 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

Composite measure of Absorption, Metabolism and Excretion of Phytochemicals (time frame: Timepoint 0 (prior to consumption), 0.5, 1.0, 1.5, 2, 4 and 6 hours post consumption). 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 NCT02342340, which also lists 4 linked publications.

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 13 May 2016.