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Completed

NCT Number: NCT02342340

Bioavailability of Compounds From Different Bean Varieties in Healthy Individuals.

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St.Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 (cooked

Other

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

Black Beans (cooked)

Other

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

Lentils (cooked)

Other

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

White Rice

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Dr. Peter Zahradka

Other

Collaborators

  • Manitoba Pulse Growers

Registry information

Official study title

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

Acronym: BBB-2014

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 19, 2015
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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