Abstract
Background
The consumption of brown rice, which contains bran and germs and is rich in fiber, micronutrients, and phytochemicals, can contribute to good physical, cognitive, and mental health. However, these health benefits and relevant mechanisms have not been fully elucidated, especially in human subjects. Therefore, we will conduct a randomized controlled trial to examine the effects of brown rice supplementation on various aspects of health and to elucidate the underlying mechanisms.
Methods
This study will be a prospective, longitudinal, double-blind, randomized, placebo-controlled trial. Eighty healthy adults aged 20 to 64 years will receive brown rice supplements or placebo for 6 months. We will assess immune function, metabolism, the gut microbiota, and physical and mental health at baseline and at the endpoint. We will also compare these data within and between intervention groups.
Discussion
This study is the first to examine the effectiveness of brown rice supplement consumption on various aspects of health, including immune, cognitive, physical and mental health. Furthermore, we hypothesize that changes in the variation in the gut microbiota play a key role in the mechanisms underlying these health effects; therefore, we will investigate how changes in the gut microbiota caused by the consumption of brown rice supplements affect health status. We hope that the information derived from this study will be useful for promoting the use of brown rice supplements as a healthy food and improving public health.
Trial registration:
University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000049330. Registered on 8 November 2022. https://rctportal.niph.go.jp/en/detail?trial_id=UMIN000049330