- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04119791
A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice
March 28, 2024 updated by: Mohammed Moghadasian, University of Manitoba
In this study 24 adult males and adult females, with overall healthy condition, will consume approximately 30 grams of wild rice every day for 28 days.
Cardiovascular risk factors will be assessed at the beginning and at the end of the study.
Study Overview
Detailed Description
Cardiovascular disorders (CVD) including hypertension, myocardial infarction and stroke are still among the top causes of mortality and morbidity in both developed and developing countries.
Several modifiable and non-modifiable risk factors play a crucial role in pathogenesis of CVD.
Among modifiable risk factors, unhealthy diets and sedentary life style have been recognized worldwide.
In this regard, many health authorities have developed guidelines to promote consumption of healthy diets and an active life style among the general population and for CVD patients.
Furthermore, recent advances in the area of food and nutrition have revealed health promoting properties for some foods beyond their nutritional values.
Such foods are generally known as "functional foods."
The Department of Food and Human Nutritional Sciences at the University of Manitoba (U of M) is well-recognized for its contribution in this area of research.
However, the effects of wild rice have not been tested in clinical trials.
Hence, a pilot study is required before performing a large clinical trial to explore the effects of wild rice consumption and its potential mechanisms.
This would not only benefit the populations, but also warranty its scope globally.
In this study, the investigators will carry out such a study on the cardiovascular benefits of wild rice in 24 women and 24 men (20-40 years old) over a period of 4 weeks.
"Test food" including fruit/vegetable salad, energy cookies and casserole will be prepared by Tall Grass Bakery, Winnipeg, Manitoba.
These foods will contain approximately 30 grams of wild rice per serving.
The participants will be recruited per our standard procedures.
After completion of recruitment procedures, including obtaining a fully informed consent form and health information, the participant will be asked to consume one serving of the "test food" every day over 28 days.
Vascular measurements, plus urine and blood samples will be collected at day 0 and day 28.
Serum lipids, inflammatory markers and fecal bacterial type, and numbers will be determined.
Study Type
Interventional
Enrollment (Estimated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohammed H Moghadasian, PhD
- Phone Number: 204-235-3934
- Email: mmoghadasian@sbrc.ca
Study Contact Backup
- Name: Khuong Le, Bsc
- Phone Number: 204-235-3954
- Email: kle@sbrc.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male
- Female
- Both genders are healthy
- 20 - 40 years old
Exclusion Criteria:
- Non-pregnant
- Non-lactating
- Non-smokers
- Not obese (Body Mass Index (BMI) < 30)
- Not currently on any medications for cardiovascular, diabetes, and cancer diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wild rice
Participants will consume one serving of the test food containing wild rice every day over 28 days.
|
30 grams of wild rice in the form salad, snack bar and soup
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wild rice alters gut microbiome.
Time Frame: 4 weeks
|
This study is designed to investigate the effects of wild rice consumption on gut microbiome diversity and population in volunteer healthy young adults.
|
4 weeks
|
Changes in gut microbiome alters macronutrient metabolism.
Time Frame: 4 weeks
|
In this study, the investigators will establish whether changes in gut microbiome due to consumption of wild rice may result in altered macronutrient metabolism by studying plasma metabolomics.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wild rice consumption improves blood lipid profile.
Time Frame: 4 weeks
|
In this study, plasma lipoprotein cholesterol concentrations will be estimated to assess the impact of wild rice consumption on the overall risk for atherosclerosis.
|
4 weeks
|
Will rice consumption improves endothelial cell function.
Time Frame: 4 weeks
|
Mobil-O-Graph techniques will be used to measure endothelial cell function in the participants prior to consumption of wild rice and after 28 days of consumption of wild rice.
This study will establish the effects of wild rice consumption on endothelial cell function.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohammed H Moghadasian, PhD, University of Manitoba
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
January 30, 2025
Study Completion (Estimated)
January 30, 2027
Study Registration Dates
First Submitted
October 1, 2019
First Submitted That Met QC Criteria
October 4, 2019
First Posted (Actual)
October 8, 2019
Study Record Updates
Last Update Posted (Actual)
March 29, 2024
Last Update Submitted That Met QC Criteria
March 28, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- HS22890
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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