Clinical trial NCT04119791: A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice
Official title: A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Diet
Healthy
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wild rice alters gut microbiome.
timeFrame: 4 weeks
measure: Changes in gut microbiome alters macronutrient metabolism.
timeFrame: 4 weeks
Secondary outcomes:
measure: Wild rice consumption improves blood lipid profile.
timeFrame: 4 weeks
measure: Will rice consumption improves endothelial cell function.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital Research Center Asper clinical
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Mohammed H Moghadasian, PhD
role: PRINCIPAL_INVESTIGATOR
References: