Efficacy of multigrain supplementation in type 2 diabetes mellitus:A pilot study protocol for a randomized intervention trial  

作　　者：Nur Anis Mohd Ariffin Mastura Mohd Sopian Lai Kuan Lee 

机构地区：[1]Food Technology Division,School of Industrial Technology,Universiti Sains Malaysia,Gelugor 11800,Pulau Pinang,Malaysia [2]Oncology and Radiological Sciences Cluster,Advanced Medical and Dental Institute,Universiti Sains Malaysia,Bertam 13200,Pulau Pinang,Malaysia

出　　处：《World Journal of Diabetes》2023年第5期606-616,共11页世界糖尿病杂志（英文版）（电子版）

摘　　要：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.

关 键 词：BETA-GLUCAN Clinical trial Multigrain Type 2 diabetes mellitus Glycemic control 

分 类 号：R587.1[医药卫生—内分泌]