跳至主要内容
临床试验/NCT04119791
NCT04119791招募中不适用

A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice

University of Manitoba2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
2
主要终点
Wild rice alters gut microbiome.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Both genders are healthy
  • 20 - 40 years old

排除标准

  • Non-pregnant
  • Non-lactating
  • Non-smokers
  • Not obese (Body Mass Index (BMI) < 30)
  • Not currently on any medications for cardiovascular, diabetes, and cancer diseases

结局指标

主要结局

Wild rice alters gut microbiome.

时间窗: 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.

时间窗: 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.

次要结局

  • Wild rice consumption improves blood lipid profile.(4 weeks)
  • Will rice consumption improves endothelial cell function.(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Moghadasian

Principal Investigator

University of Manitoba

研究点 (2)

Loading locations...

相似试验