PMID- 37273251 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230606 IS - 1948-9358 (Print) IS - 1948-9358 (Electronic) IS - 1948-9358 (Linking) VI - 14 IP - 5 DP - 2023 May 15 TI - Efficacy of multigrain supplementation in type 2 diabetes mellitus: A pilot study protocol for a randomized intervention trial. PG - 606-616 LID - 10.4239/wjd.v14.i5.606 [doi] AB - BACKGROUND: Uncontrolled type 2 diabetes mellitus (T2DM) may lead to microvascular complications (nephropathy, retinopathy, and neuropathy) and cardiovascular diseases. The beta-glucan content in grains has the potential to improve insulin sensitivity, lowering postprandial glucose response and reducing inflammation degrees. A proper combination of grains not only satisfies human body's need, but also provides essential and reasonable nutritional contents. However, no trial has been conducted to evaluate the roles of multigrain in T2DM. AIM: To determine the efficacy of multigrain supplementation among T2DM patients. METHODS: From October 2020 to June 2021, a total of 50 adults living with T2DM, who were receiving standard diabetes care at Day Care Clinic, were randomized into either a supplementation group or a control group. The supplementation group received twice daily 30 g multigrain supplement (equivalent to 3.4 g beta-glucan) with standard medication for 12 wk, while the control group was prescribed with standard medication. Parameters such as glycemic control (HbA1c, FPG, and HOMO-IR), cardiometabolic profile (lipid profile, renal function test, and liver function test), oxidative stress status, nutritional status, and quality of life (QoL) were assessed at two time points: Baseline and the end of the treatment period (week 12). RESULTS: The primary outcomes were the mean difference of glycated haemoglobin (%), fasting plasma glucose, and serum insulin as intervention effects. Secondary outcomes included the measurement of cardiometabolic profile, antioxidative and oxidative stress status, nutritional status indices, and QoL. Tertiary outcomes involved the determination of safety and tolerability, and supplementation compliance. CONCLUSION: The present clinical trial will reveal the effectiveness of multigrain supplementation among T2DM patients for the improvement of diabetes management. CI - (c)The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved. FAU - Mohd Ariffin, Nur Anis AU - Mohd Ariffin NA AD - Food Technology Division, School of Industrial Technology, Universiti Sains Malaysia, Gelugor 11800, Pulau Pinang, Malaysia. FAU - Mohd Sopian, Mastura AU - Mohd Sopian M AD - Oncology and Radiological Sciences Cluster, Advanced Medical and Dental Institute, Universiti Sains Malaysia, Bertam 13200, Pulau Pinang, Malaysia. FAU - Lee, Lai Kuan AU - Lee LK AD - Food Technology Division, School of Industrial Technology, Universiti Sains Malaysia, Gelugor 11800, Pulau Pinang, Malaysia. l.k.lee@usm.my. LA - eng PT - Clinical Trial PL - United States TA - World J Diabetes JT - World journal of diabetes JID - 101547524 PMC - PMC10236996 OTO - NOTNLM OT - Beta-glucan OT - Clinical trial OT - Glycemic control OT - Multigrain OT - Type 2 diabetes mellitus COIS- Conflict-of-interest statement: (Oat King(R)) 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. EDAT- 2023/06/05 13:04 MHDA- 2023/06/05 13:05 PMCR- 2023/05/15 CRDT- 2023/06/05 11:44 PHST- 2022/12/23 00:00 [received] PHST- 2023/03/02 00:00 [revised] PHST- 2023/04/10 00:00 [accepted] PHST- 2023/06/05 13:05 [medline] PHST- 2023/06/05 13:04 [pubmed] PHST- 2023/06/05 11:44 [entrez] PHST- 2023/05/15 00:00 [pmc-release] AID - 10.4239/wjd.v14.i5.606 [doi] PST - ppublish SO - World J Diabetes. 2023 May 15;14(5):606-616. doi: 10.4239/wjd.v14.i5.606.