Postprandial Effects of Bean and Whole Grain Consumption on Arterial Stiffness

A Pilot Study to Examine the Effect of Consuming Beans and Whole Grains at Breakfast on Postprandial Vascular Responses in People With Arterial Stiffness

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.

Study Overview

• Status: Recruiting
• Conditions: Arterial Stiffness
• Intervention / Treatment: Dietary supplement: black beans; Dietary supplement: wheat berries; Dietary supplement: white rice

Detailed Description

This is a single site, single-blinded, randomized, controlled crossover study designed to compare the vascular responses of males and females with arterial stiffness before and 2 hours after ingestion of black beans or whole grains (wheat) or white rice (isocaloric comparator).

Recruitment will consist of a total of 10 participants with arterial stiffness. Participants will be recruited through advertisement from the local community.

The study will be conducted at the Asper Clinical Research Institute, 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 screening visit to provide a fasting blood sample (and females a urine sample) and assess the presence of arterial stiffness (by PWV) to determine eligibility. Should the participant be eligible to participate, they will be scheduled for three study visits to obtain fasting blood samples and assess postprandial blood vessel function. During the first study visit period, participants will be asked to complete a Food Habits Questionnaire.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter C Zahradka, PhD; Phone Number: 2042353507; Email: peter.zahradka@umanitoba.ca
• Study Contact Backup: Name: Carla G Taylor, PhD; Phone Number: 2042581361; Email: carla.taylor@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0T5
      • Recruiting
      • Asper Clinical Research Institute
      • Contact: Peter C Zahradka, PhD; Phone Number: 2042353507; Email: peter.zahradka@umanitoba.ca
      • Contact: Danielle Perrera, MSc; Phone Number: 2042581207; Email: dperrera@sbrc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male, or non-pregnant, non-lactating female, 45 to 65 years of age;
2. Brachial-ankle pulse wave velocity >1400 cm/s on at least one side;
3. Plasma creatinine ≤265 µmol/L;
4. Aspartate aminotransferase <160 U/L, andalanine aminotransferase <150 U/L;
5. Glycated hemoglobin ≤6.5%;
6. LDL-cholesterol <5 mmol/L;
7. Stable regime if taking vitamin and mineral/dietary/herbal supplements for the past 1 month and while participating in the study;
8. 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;
9. 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;
10. Willing to comply with the protocol requirements and procedures;
11. Willing to provide informed consent.

Exclusion Criteria:

1. 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;
2. Taking vasoactive medications (e.g., ACE inhibitors, ARBs, AGE-breakers, thiazolidinediones, beta-blockers, statins, insulin, etc.);
3. Blood pressure >160 mmHg systolic and/or >100 mmHg diastolic;
4. History of gastrointestinal reactions or allergies to beans, bean flour, wheat, wheat flour, gluten, or rice;
5. Body weight exceeds the capacity of the DEXA (350 lbs);
6. Current (within the past 30 days) bacterial, viral or fungal infection;
7. Bleeding disorder;
8. Amputations of upper or lower extremities on both sides;
9. Any acute medical condition or surgical intervention within the past 3 months;
10. Drug and/or alcohol abuse;
11. Psychological disorder(s);
12. Unable to fast overnight;
13. Unable to take prescribed medication without food;
14. Unable to obtain vascular function measurements and/or blood sample at the screening or first study visits;
15. Not fully vaccinated for COVID-19.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Black Beans (cooked); 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 water whenever necessary 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; ¾ cup of cooked black beans
Active Comparator: Whole Wheat Grain (cooked); 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 water whenever necessary 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; ¾ cup of cooked whole wheat grain
Placebo Comparator: White Rice (cooked); 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 water whenever necessary 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; ¾ cup of cooked white rice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Augmentation index at 2 hours	Pulse wave analysis using a Mobil-O-Graph PWA Monitor 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 Pulse wave velocity at 2 hours	Pulse wave analysis using a Mobil-O-Graph PWA Monitor will be used to measure the pulse wave velocity (PWV), 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 Mobil-O-Graph PWA Monitor 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive protein	A fasting venous blood sample will be analyzed for C-reactive protein to assess inflammatory status	Time points 0 (prior to consumption) and 2 hours post consumption.
soluble VCAM1	A fasting venous blood sample will be analyzed for soluble VCAM1 (vascular cell adhesion molecule-1) to assess changes in endothelial function	Time points 0 (prior to consumption) and 2 hours post consumption.

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HS25221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No