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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| black beans | Dietary Supplement | ¾ cup of cooked black beans |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline blood pressure at 2 hours | A SphygmoCor XCEL device will be used to measure the blood pressure prior to consumption of the test products, and at 2 hours post-consumption. | Time points 0 (prior to consumption) and 2 hours post consumption. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asper Clinical Research Institute | Winnipeg | Manitoba | R3E 0T5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40218917 | Derived | 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. |
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| wheat berries |
| Dietary Supplement |
¾ cup of cooked whole wheat grain |
|
| white rice | Dietary Supplement | ¾ cup of cooked white rice |
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