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

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.