Clinical trial NCT02342340: Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.
Official title: A Blinded, Randomized, Controlled Study to Examine the Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Beans, Lentils, Bioavailability, Phytochemical Absorption
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Pulse Growers
First posted: 2015-01-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite measure of Absorption, Metabolism and Excretion of Phytochemicals
timeFrame: Timepoint 0 (prior to consumption), 0.5, 1.0, 1.5, 2, 4 and 6 hours post consumption
Secondary outcomes:
measure: Changes in parameters of arterial stiffness through pulse wave analysis (PWA)
timeFrame: Time points 0 (prior to consumption) and 2 and 6 hours post consumption.
measure: Satiety Questionnaire
timeFrame: 5 hours after consumption of study product
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St.Boniface Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Peter Zahradka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.