Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.

Dr. Peter Zahradka8 enrolled

Overview

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

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

St.Boniface Hospital

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

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).

Time frame: Timepoint 0 (prior to consumption), 0.5, 1.0, 1.5, 2, 4 and 6 hours post consumption

Secondary Outcomes

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 frame: 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.

Time frame: 5 hours after consumption of study product

Data from ClinicalTrials.gov

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