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Dietary Supplement
Beans & Whole Grains for Arterial Stiffness
N/A
Recruiting
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male, or non-pregnant, non-lactating female, 45 to 65 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time points 0 (prior to consumption) and 2 hours post consumption.
Awards & highlights
Study Summary
This trial tests how different foods affect how blood flows through arteries in 10 people; 3 visits to compare black beans, grains & white rice.
Who is the study for?
This trial is for men and non-pregnant, non-lactating women aged 45-65 with arterial stiffness. Participants must not have donated blood recently, be willing to follow the study's rules, and have certain health markers within specific ranges. They can't take vasoactive meds, have high blood pressure or a recent serious infection or medical event.Check my eligibility
What is being tested?
The study tests how black beans, whole grains (wheat berries), or white rice consumed at breakfast affect arterial stiffness in participants. It's a controlled trial where each person tries all three foods across different visits to see which one has better effects on their arteries.See study design
What are the potential side effects?
Since this trial involves common food items rather than medications, side effects are minimal but may include gastrointestinal discomfort or allergic reactions if participants have unknown sensitivities to these foods.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man or a woman not pregnant or breastfeeding, aged 45-65.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time points 0 (prior to consumption) and 2 hours post consumption.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time points 0 (prior to consumption) and 2 hours post consumption.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline Augmentation index at 2 hours
Change from baseline Pulse wave velocity at 2 hours
Change from baseline Reflection magnitude at 2 hours
Secondary outcome measures
C-reactive protein
soluble VCAM1
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Black Beans (cooked)Active Control1 Intervention
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.
Group II: Whole Wheat Grain (cooked)Active Control1 Intervention
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.
Group III: White Rice (cooked)Placebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,516 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart event, stroke, or surgery for heart disease, or I have chronic kidney, liver (not fatty liver), lung diseases, rheumatoid arthritis, an immune disorder like MS or leukemia, cancer in the last 5 years, neurological or gastrointestinal disorders.My weight is over 350 lbs.I have had an infection in the last 30 days.I am a man or a woman not pregnant or breastfeeding, aged 45-65.I have not had any major medical conditions or surgeries in the last 3 months.You have a history of using drugs or alcohol excessively.I am taking medications that affect blood pressure or heart health.I have a bleeding disorder.You have a mental health condition.You are unable to take the medication as directed, without having to eat food with it.You have had allergic reactions or gastrointestinal issues in the past when consuming beans, wheat, gluten, or rice.You have been taking vitamin, mineral, dietary, or herbal supplements consistently for the past month and will continue taking them during the study.I have had amputations on both my arms and legs.
Research Study Groups:
This trial has the following groups:- Group 1: Black Beans (cooked)
- Group 2: Whole Wheat Grain (cooked)
- Group 3: White Rice (cooked)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being recruited to participate in this clinical investigation?
"Confirmative, the clinicaltrial.gov portal details that this scientific experiment is currently recruiting candidates. This research was initially posted on April 1st 2023 and has been recently updated on April 24th 2023. 10 subjects are needed at just one centre of study."
Answered by AI
Is there eligibility criteria to join this medical trial?
"Only 10 participants will be accepted into this trial, who must have arterial stiffness and a chronological age between 45 to 65 years old."
Answered by AI
Are elderly individuals accepted in this research trial?
"According to the terms of engagement, those hoping to be considered for inclusion must fall between a minimum age limit of 45 and maximum age cap of 65."
Answered by AI
Is this research endeavor currently enrolling participants?
"Affirmative, according to clinicaltrials.gov data this trial is still accepting participants. It was initially advertised on April 1st 2023 and the post was most recently updated on April 24th. The total number of required patients stands at 10 with a single medical centre enrolling them all."
Answered by AI
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