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Recruiting NCT04119791

A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice

No phase Interventional Healthy Diet Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: wild rice.
Who it may be relevant to
Registry conditions: Healthy Diet, Healthy. Basic parameters: 20 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other wild rice
    30 grams of wild rice in the form salad, snack bar and soup

Primary outcome measures

  • Wild rice alters gut microbiome. [Time frame: 4 weeks]
  • Changes in gut microbiome alters macronutrient metabolism. [Time frame: 4 weeks]
Secondary outcome measures (2)
  • Wild rice consumption improves blood lipid profile. [Time frame: 4 weeks]
  • Will rice consumption improves endothelial cell function. [Time frame: 4 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Canada · 1 center
  • St. Boniface Hospital Research Center Asper clinical — Winnipeg

Identifiers

NCT: NCT04119791 · HS22890

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗