Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.

Healthy Clinical Trial

— BBB-2014  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342340
• Other study ID #: B2014:122
• Status: Completed
• Phase: N/A
• First received: January 14, 2015
• Last updated: May 12, 2016
• Start date: January 2015
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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). Eligible participants will attend 6 in-person clinic visits for comparative testing of the 4 bean varieties versus lentils and rice.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Males or females, =18 and =50 years;

2. 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%;

3. Blood pressure <140/90

4. Body mass index (BMI) =20 and <30;

5. Stable regime for the past 3 months if taking vitamin and mineral/dietary/ herbal supplements;

6. Agree not to eat beans or bean-based foods, lentils or lentil-based foods, or consume isoflavone supplements while participating in this study;

7. Willing to comply with the protocol requirements;

8. Willing to provide informed consent.

Exclusion Criteria:

1. Allergies to beans, bean flour or bean products, lentils or rice;

2. Presence of a clinically diagnosed disease affecting the circulatory, respiratory, immune, skeletal, urinary, muscular, endocrine, digestive, nervous or reproductive system that requires medical treatment;

3. 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;

4. Weight loss of =3 kg of body weight within the 6 months prior to enrolling in the study;

5. Current (within the last month) bacterial, viral or fungal infection, or over-the-counter medication within the past 72 hours;

6. Pregnant or lactating;

7. Unable to obtain blood samples at the screening visit or the first study visit.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Canada	St.Boniface Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Peter Zahradka	Manitoba Pulse Growers

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Timepoint 0 (prior to consumption), 0.5, 1.0, 1.5, 2, 4 and 6 hours post consumption	No
Secondary	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.	Time points 0 (prior to consumption) and 2 and 6 hours post consumption.	No
Secondary	Satiety Questionnaire	Participants will complete a Satiety Questionnaire 5 hours after consumption of the study product.	5 hours after consumption of study product	No

External Links

•   Canadian Centre for Agri-Food Research in Health and Medicine