Effects of a combination supplement containing Lysine, Vitamin C and Zinc on oxidative stress, glycaemic control and formation of Advanced Glycosylation End Products (AGEs) in patients with type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical trial

INTERVENTION: The study will be carried out at Nawaloka Hospital Research and Education Foundation (NHHEF), Nawaloka Hospitals PLC, Colombo, Sri Lanka. Consenting participants meeting inclusion/exclusion criteria will be randomized into 2 arms using stratified block randomization. Arm 1 (intervention arm) will receive a capsule containing Lysine (Amino acid) 500mg, Zinc 5mg and Vitamin C 50mg as active ingredients, to be taken two capsules at a time, three times daily for six months Arm 2 (control arm) will receive an identical matching placebo at the same frequency for the same duration of six months. The placebo will be manufactured to have a similar appearance, shape, weight, and color as the intervention capsule. Placebo capsule will contain magnesium stearate, microcrystalline cellulose and silicone. The investigators, health care providers, patients and data collectors would be blinded to the treatment allocations. Participants in both groups will receive uniform advice about diet and physical activity. CONDITION: Diabetes PRIMARY OUTCOME: Change in HbA1c from baseline in treatment and placebo arms; [At baseline; End of 3 months; End of study (at 6 months)]; Change in Fasting Blood Glucose (FBG) from baseline in treatment and placebo arms [At baseline; End of 3 months; End of study (at 6 months)]; Change in formation of Advanced Glycosylation End Products (AGEs) from baseline in treatment and placebo arms [At baseline; End of 3 months; End of study (at 6 months) ]; Change in Oxidative Stress from baseline in treatment and placebo arms [At baseline; End of 3 months; End of study (at 6 months) ]; SECONDARY OUTCOME: Percentage of patients with HbA1c <7.0% in treatment and placebo arms [At baseline ; End of study (at 6 months)]; Percentage of patients with Fasting Blood Glucose (FBG) level < 126 mg/dl in treatment and placebo arms ; [At baseline ; End of study (at 6 months)]; Change in insulin resistance and Beta‐cell function in treatment and placebo arms measured by Homeostatic model assessment [At baseline ; End of study (at 6 months)]; Change in Body Mass Index and other anthropometric parameters (waist circumference, hip circumference, waist‐to‐hip ratio) in treatment and placebo arms [At baseline ; End of study (at 6 months)]; Change in Blood Pressure (systolic and diastolic) in treatment and placebo arms [At baseline ; End of study (at 6 months)]; Change in the Lipid Profile (Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides) in treatment and placebo arms [At baseline ; End of study (at 6 months)]; INCLUSION CRITERIA: a) Age between 20‐70 years b) Both male and female c) Currently on metformin or sulphonyluria or both (less than or equal to two oral hypoglcaemic agents) for the last 3 months d) HbA1c > 7.5%