Randomized Clinical Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. May 15, 2023; 14(5): 606-616
Published online May 15, 2023. doi: 10.4239/wjd.v14.i5.606
Efficacy of multigrain supplementation in type 2 diabetes mellitus: A pilot study protocol for a randomized intervention trial
Nur Anis Mohd Ariffin, Mastura Mohd Sopian, Lai Kuan Lee
Nur Anis Mohd Ariffin, Lai Kuan Lee, Food Technology Division, School of Industrial Technology, Universiti Sains Malaysia, Gelugor 11800, Pulau Pinang, Malaysia
Mastura Mohd Sopian, Oncology and Radiological Sciences Cluster, Advanced Medical and Dental Institute, Universiti Sains Malaysia, Bertam 13200, Pulau Pinang, Malaysia
Author contributions: Mohd Ariffin NA, Mohd Sopian M, and Lee LK were responsible for the study conception and design, data acquisition, analysis, and interpretation, and manuscript drafting; Mohd Ariffin NA and Lee LK critically reviewed and revised the article for important intellectual content of the manuscript; all authors reviewed and approved the final version of the manuscript to be published.
Institutional review board statement: The study was reviewed and approved by the Human Research Ethics Committee of Universiti Sains Malaysia (No: USM/JEPeM/20030183).
Clinical trial registration statement: This study is registered in the clinical trial registry (ClinicalTrials.gov), with the registration ID: NCT04597229.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrolment.
Conflict-of-interest statement: (Oat King®) was funded by TG Ocean Health Food Industries Sdn Bhd to Lai Kuan Lee. Nevertheless, the funder has no role in the conduct of the research, including the study design, data collection, analysis, and interpretation, preparation of the article, and in the decision to submit the article for publication. Mohd Ariffin NA and Mohd Sopian M declare no competing interest.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Lai Kuan Lee, PhD, Senior Lecturer, Food Technology Division, School of Industrial Technology, Universiti Sains Malaysia, Gelugor 11800, Pulau Pinang, Malaysia. l.k.lee@usm.my
Received: December 23, 2022
Peer-review started: December 23, 2022
First decision: February 20, 2023
Revised: March 2, 2023
Accepted: April 10, 2023
Article in press: April 10, 2023
Published online: May 15, 2023
Processing time: 143 Days and 10.5 Hours
ARTICLE HIGHLIGHTS
Research background

Type II diabetes mellitus (T2DM) has emerged as a major public health challenge around the world. Diet is a major lifestyle factor that can greatly influence the incidence and progression of T2DM. The notion that foods not only provide basic nutrition but can also prevent diseases and ensure good health and longevity is now attaining greater prominence.

Research motivation

Typically, grains, with its rich non-starch polysaccharides content, are receiving concern among the scientific communities. Multigrain is rich with thiamine, riboflavin, pantothenic acid, iron, zinc, and copper, and it can be prepared using different preparation processes, which usually comprises a high amount of dietary fiber content. Multigrain consumption is indeed a more representative dietary intervention as compared to single grain intake. There is a need to examine whether supplementation with multigrain, a more representative dietary regimen to human routine consumption pattern, would yield better outcomes among T2DM patients.

Research objectives

The objectives of the present study were to evaluate the effects of multigrain supplementation on glycemic control, cardiometabolic profile, oxidative stress, nutritional status, and quality of life (QoL) among T2DM patients. The safety, tolerability, and adherence of the supplementation were evaluated.

Research methods

Fifty T2DM patients have been randomly assigned to receive either 60 g multigrain supplementation (containing 3.4 g beta-glucan) coupled with prescribed standard medication regimen (n = 25), or standard medication regimen alone (n = 25) for 12 wk. Study outcomes involved the changes of glycemic control, cardiometabolic profile, oxidative stress, nutritional status, and QoL.

Research results

No result is provided as this is a pilot study protocol for a human clinical trial.

Research conclusions

This is a pioneer, pilot clinical trial that aims to evaluate the efficacy of high beta-glucan multigrain supplementation among T2DM patients. Important trial outcomes, such as glycemic control, peripheral antioxidative capacity, cardiometabolic health, nutritional status, QoL, safety, and compliance, have been studied extensively. The results of the trial are important to suggest a scientifically driven complementary dietary agent for better management of T2DM.

Research perspectives

The findings are expected to contribute and expand the fundamental mechanism of the role of multigrain as a complementary management agent in diabetic physiology.