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
Core Tip

Core Tip: This is the first human clinical trial aimed to evaluate the effectiveness of multigrain supplementation among type 2 diabetes mellitus patients. The changes of glycemic control, cardiometabolic profile, oxidative stress status, nutritional status, and quality of life were measured. Our study also evaluated the safety, tolerability, and compliance of the supplementation.