Postprandial Effects of Bean and Whole Grain Consumption on Arterial Stiffness

NCT05818358 | Completed

• 1 other identifier: HS25221
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single site, single-blinded, controlled randomized crossover clinical trial designed to compare the effects of black beans or whole grains or white rice at breakfast on postprandial vascular responses in males and females with arterial stiffness (n=10). Eligible participants will be asked to attend 3 in-person visits for comparative testing of black beans versus whole grains versus white rice.

Conditions

Arterial Stiffness

Outcome Measures

Primary Outcomes (2)

• Change from baseline Augmentation index at 2 hours

  Pulse wave analysis using a SphygmoCor XCEL device will be used to measure the augmentation index (AIx), an indicator of arterial stiffness, prior to consumption of the test products, and at 2 hours post-consumption.

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

• Change from baseline Reflection magnitude at 2 hours

  Pulse wave analysis using a SphygmoCor XCEL device will be used to measure the reflection magnitude, an indicator of arterial stiffness, prior to consumption of the test products, and at 2 hours post-consumption.

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

Secondary Outcomes (1)

• Change from baseline blood pressure at 2 hours

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

Study Arms (3)

Black Beans (cooked)

ACTIVE COMPARATOR

At one of the three visits, participants will consume a ¾ cup of cooked black beans. Participants will be provided with 100 ml of water with the food, and will be allowed to drink up to another 150 mL of water during the 2 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 3 visits have been completed.

Dietary Supplement: black beans

Whole Wheat Grain (cooked)

ACTIVE COMPARATOR

At one of the three visits, participants will consume a ¾ cup of cooked whole wheat grain. Participants will be provided with 100 ml of water with the food, and will be allowed to drink up to another 150 mL of water during the 2 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 3 visits have been completed.

Dietary Supplement: wheat berries

White Rice (cooked)

PLACEBO COMPARATOR

At one of the three 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 up to another 150 mL of water during the 2 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 3 visits have been completed.

Dietary Supplement: white rice

Interventions

black beans DIETARY_SUPPLEMENT

¾ cup of cooked black beans

Black Beans (cooked)

wheat berries DIETARY_SUPPLEMENT

¾ cup of cooked whole wheat grain

Whole Wheat Grain (cooked)

white rice DIETARY_SUPPLEMENT

¾ cup of cooked white rice

White Rice (cooked)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, or non-pregnant, non-lactating female, 45 to 65 years of age;
• Brachial-ankle pulse wave velocity \>1400 cm/s on at least one side;
• Plasma creatinine ≤265 µmol/L;
• Aspartate aminotransferase \<160 U/L, andalanine aminotransferase \<150 U/L;
• Glycated hemoglobin ≤6.5%;
• LDL-cholesterol \<5 mmol/L;
• Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 month and while participating in the study;
• Has not donated blood or blood products (e.g. platelets) during the past 2 months and willing to continue doing so while participating in the study;
• Not participating in another dietary intervention trial for the past month and willing to not start another dietary intervention trial for the duration of this study;
• Willing to comply with the protocol requirements and procedures;
• Willing to provide informed consent.

You may not qualify if:

• Has experienced a cardiovascular event (e.g. heart attack, stroke) or had a surgical procedure for cardiovascular disease (e.g. bypass, stent), presence of clinically diagnosed cardiac arrhythmia or valve stenosis, chronic renal disease, liver disease (with exception of fatty liver), lung disease, rheumatoid arthritis, immune disorder or disease (e.g. multiple sclerosis, leukemia), cancer in the previous 5 years, neurological disorders, or gastrointestinal disorders;
• Taking vasoactive medications (e.g., ACE inhibitors, ARBs, AGE-breakers, thiazolidinediones, beta-blockers, statins, insulin, etc.);
• Blood pressure \>160 mmHg systolic and/or \>100 mmHg diastolic;
• History of gastrointestinal reactions or allergies to beans, bean flour, wheat, wheat flour, gluten, or rice;
• Body weight exceeds the capacity of the DEXA (350 lbs);
• Current (within the past 30 days) bacterial, viral or fungal infection;
• Bleeding disorder;
• Amputations of upper or lower extremities on both sides;
• Any acute medical condition or surgical intervention within the past 3 months;
• Drug and/or alcohol abuse;
• Psychological disorder(s);
• Unable to fast overnight;
• Unable to take prescribed medication without food;
• Unable to obtain vascular function measurements and/or blood sample at the screening or first study visits;
• Not fully vaccinated for COVID-19.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Asper Clinical Research Institute

Winnipeg, Manitoba, R3E 0T5, Canada

Location

Related Publications (1)

• Zahradka P, Perera D, Charney J, Taylor CG. Distinct Effects of Wheat and Black Bean Consumption on Postprandial Vascular Responses in People with Arterial Stiffness: A Pilot Randomized Cross-Over Study. Nutrients. 2025 Mar 27;17(7):1159. doi: 10.3390/nu17071159.

  PMID: 40218917 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 18, 2023
• Study Start: April 1, 2023
• Primary Completion: March 22, 2024
• Study Completion: April 30, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

CA (1)