Arterial StiffnessNCT05818358
Postprandial Effects of Bean and Whole Grain Consumption on Arterial Stiffness
A study testing black beans, wheat berries and white rice in people with Arterial Stiffness, run by University of Manitoba at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Arterial Stiffness
- What is being tested?
- black beans, wheat berries and white rice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Arterial Stiffness
- Being tested
- black beans, wheat berries, white rice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
black beansDietary supplement
¾ cup of cooked black beans
wheat berriesDietary supplement
¾ cup of cooked whole wheat grain
white riceDietary supplement
¾ cup of cooked white rice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: white rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time points 0 (prior to consumption) and 2 hours post consumption.
Secondary outcomes (1)
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.
Measured: Time points 0 (prior to consumption) and 2 hours post consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Apr 2023
- Primary completion22 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Peter Zahradka, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818358
- Sponsor's protocol ID
- HS25221
- Status last verified
- Feb 2025
- First submitted
- 16 Mar 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40218917
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Examine the Effect of Consuming Beans and Whole Grains at Breakfast on Postprandial Vascular Responses in People With Arterial Stiffness
- ClinicalTrials.gov ID
- NCT05818358
- Acronym / sponsor ID
- HS25221
- Conditions
- Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Black Beans (cooked) | Active comparator | Dietary Supplement: black beansAt 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. |
| Whole Wheat Grain (cooked) | Active comparator | Dietary Supplement: wheat berriesAt 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. |
| White Rice (cooked) | Placebo comparator | Dietary Supplement: white riceAt 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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%;
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| black beans¾ cup of cooked black beans | Dietary supplement | Black Beans (cooked) |
| wheat berries¾ cup of cooked whole wheat grain | Dietary supplement | Whole Wheat Grain (cooked) |
| white rice¾ cup of cooked white rice | Dietary supplement | White Rice (cooked) |
Primary outcome
Change from baseline Augmentation index at 2 hours
Time frame: Time points 0 (prior to consumption) and 2 hours post consumption.
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.
Change from baseline Reflection magnitude at 2 hours
Time frame: Time points 0 (prior to consumption) and 2 hours post consumption.
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.
1 secondary outcome
Change from baseline blood pressure at 2 hours
Time frame: Time points 0 (prior to consumption) and 2 hours post consumption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 40218917Zahradka 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing black beans, wheat berries and white rice in people with Arterial Stiffness, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Augmentation index at 2 hours (time frame: Time points 0 (prior to consumption) and 2 hours post consumption.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05818358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.