Healthy DietNCT04119791
A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice
A study testing wild rice in people with Healthy Diet and Healthy, run by University of Manitoba at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet, Healthy
- What is being tested?
- wild rice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2024to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Female
- Both genders are healthy
- 20 - 40 years old
Who cannot join
- Non-pregnant
- Non-lactating
- Non-smokers
- Not obese (Body Mass Index (BMI) < 30)
- Not currently on any medications for cardiovascular, diabetes, and cancer diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Boniface Hospital Research Center Asper clinical
Winnipeg, Manitoba, R2H2A6
About this study
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.
Read the 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.
- Conditions
- Healthy Diet, Healthy
- Being tested
- wild rice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wild riceOther
30 grams of wild rice in the form salad, snack bar and soup
| Study group | Role | What they receive |
|---|---|---|
| Wild rice | Experimental | Participants will consume one serving of the test food containing wild rice every day over 28 days. Receives: Other: wild rice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wild rice alters gut microbiome.
This study is designed to investigate the effects of wild rice consumption on gut microbiome diversity and population in volunteer healthy young adults.
Measured: 4 weeks
Changes in gut microbiome alters macronutrient metabolism.
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.
Measured: 4 weeks
Secondary outcomes (2)
Wild rice consumption improves blood lipid profile.
In this study, plasma lipoprotein cholesterol concentrations will be estimated to assess the impact of wild rice consumption on the overall risk for atherosclerosis.
Measured: 4 weeks
Will rice consumption improves endothelial cell function.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start5 Nov 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Moghadasian, University of Manitoba
- Investigators
- Mohammed H Moghadasian, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119791
- Sponsor's protocol ID
- HS22890
- Status last verified
- Feb 2025
- First submitted
- 1 Oct 2019
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice
- ClinicalTrials.gov ID
- NCT04119791
- Acronym / sponsor ID
- HS22890
- Conditions
- Healthy Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 8 Oct 2019 (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.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wild rice | Experimental | Other: wild riceParticipants will consume one serving of the test food containing wild rice every day over 28 days. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Female
- Both genders are healthy
- 20 - 40 years old
Key exclusion criteria (5 listed)
- Non-pregnant
- Non-lactating
- Non-smokers
- Not obese (Body Mass Index (BMI) < 30)
- Not currently on any medications for cardiovascular, diabetes, and cancer diseases
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 |
|---|---|---|
| wild rice30 grams of wild rice in the form salad, snack bar and soup | Other | Wild rice |
Primary outcome
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.
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.
2 secondary outcomes
Wild rice consumption improves blood lipid profile.
Time frame: 4 weeks
Will rice consumption improves endothelial cell function.
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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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.
Mohammed H Moghadasian, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wild rice in people with Healthy Diet and Healthy, 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Mar 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed H Moghadasian, PhD (204-235-3934, mmoghadasian@sbrc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wild rice alters gut microbiome. (time frame: 4 weeks). 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?
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 3 Mar 2025.