Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.

NCT02342340 | Completed

• 1 other identifier: B2014:122
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Beans, Lentils, Bioavailability, Phytochemical Absorption

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Changes in parameters of arterial stiffness through pulse wave analysis (PWA)

  Time points 0 (prior to consumption) and 2 and 6 hours post consumption.

• Satiety Questionnaire

  5 hours after consumption of study product

Study Arms (6)

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.

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.

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.

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.

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.

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.

Other: White Rice

Interventions

Navy Beans (cooked) OTHER

One time consumption of 3/4 cup of cooked navy beans.

Navy Beans (cooked)

Red Kidney Beans (cooked) OTHER

One time consumption of 3/4 cup of cooked red kidney beans.

Red Kidney Beans (cooked)

Pinto Beans (cooked OTHER

One time consumption of 3/4 cup of cooked pinto beans.

Pinto Beans (cooked)

Black Beans (cooked) OTHER

One time consumption of 3/4 cup of cooked black beans.

Black Beans (cooked)

Lentils (cooked) OTHER

One time consumption of 3/4 cup of cooked lentils.

Lentils (cooked)

White Rice OTHER

One time consumption of 3/4 cup of cooked white rice.

White Rice (cooked)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Peter Zahradka: lead
• Manitoba Pulse Growers: collaborator

Study Sites (1)

St.Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related 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.

  PMID: 24063808 BACKGROUND

• 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.

  PMID: 24075762 BACKGROUND

• 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.

  PMID: 24957762 BACKGROUND

• 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.

  PMID: 24261687 BACKGROUND

Related Links

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

MeSH Terms

Interventions

Cooking

Intervention Hierarchy (Ancestors)

Food Handling; Food Industry; Industry; Technology, Industry, and Agriculture

Study Officials

• Peter Zahradka, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Professor

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 19, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

CA (1)