- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02342340
Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals. (BBB-2014)
A Blinded, Randomized, Controlled Study to Examine the Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.
Study Overview
Status
Conditions
Detailed Description
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).
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R2H 2A6
- St.Boniface Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
One time consumption of 3/4 cup of cooked navy beans.
|
Active Comparator: 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.
|
One time consumption of 3/4 cup of cooked red kidney beans.
|
Active Comparator: Pinto Beans (cooked)
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.
|
One time consumption of 3/4 cup of cooked pinto beans.
|
Active Comparator: 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.
|
One time consumption of 3/4 cup of cooked black beans.
|
Active Comparator: 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.
|
One time consumption of 3/4 cup of cooked lentils.
|
Placebo Comparator: White Rice (cooked)
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.
|
One time consumption of 3/4 cup of cooked white rice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Timepoint 0 (prior to consumption), 0.5, 1.0, 1.5, 2, 4 and 6 hours post consumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
Time points 0 (prior to consumption) and 2 and 6 hours post consumption.
|
Satiety Questionnaire
Time Frame: 5 hours after consumption of study product
|
Participants will complete a Satiety Questionnaire 5 hours after consumption of the study product.
|
5 hours after consumption of study product
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Zahradka, PhD, University of Manitoba
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- B2014:122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Navy Beans (cooked)
-
M.D. Anderson Cancer CenterActive, not recruitingColorectal Cancer PreventionUnited States
-
University of TorontoOntario Ministry of Agriculture, Food and Rural AffairsCompletedHypertension | Obesity | Diabetes | Overweight | Metabolic SyndromeCanada
-
Arizona State UniversityUnited States Dry Bean CouncilCompletedType 2 Diabetes Mellitus | Blood GlucoseUnited States
-
Colorado State UniversityNational Cancer Institute (NCI); Poudre Valley Health SystemCompletedColorectal Cancer Control and PreventionUnited States
-
Cornell UniversityInstituto Nacional de Salud Publica, MexicoCompleted
-
University of Colorado, Colorado SpringsIowa State UniversityCompletedType 2 Diabetes
-
M.D. Anderson Cancer CenterTerminated
-
University of ManitobaGlycemic Index Laboratories, Inc; Agriculture and Agri-Food Canada; Saskatchewan...CompletedObesity | HypercholesterolemiaCanada
-
Instituto de Cardiologia do Rio Grande do SulCompleted
-
Ain Shams UniversityUnknownGlucose-6-Phosphate Dehydrogenase DeficiencyEgypt