Effects of Curcumin and Amla Co-supplementation on Lipid Profile, Glycemic Status, Antioxidant Indices, Inflammatory Factor, and Liver Enzymes in Type 2 Diabetes Patients: A Double-Blind, Randomized Controlled Trial Protocol

Abstract

Background: Limited access to conventional treatments for type 2 diabetes mellitus (T2DM) necessitated alternative therapies. Curcumin and Amla, both medicinal plants, exhibited therapeutic properties. Their combination might have yielded synergistic effects, enhancing antioxidant defense, reducing inflammation, and improving glycemic control and lipid profiles more effectively than either agent alone. This approach aimed to develop an intervention for managing T2DM.. Objectives: This study evaluated the combined effects of curcumin and Amla on lipid profiles, glycemic status, inflammation, antioxidant levels, and liver enzymes in patients with T2DM. Methods: This double-blind, randomized controlled trial involved 50 patients with T2DM from the Ahvaz Jundishapur University of Medical Sciences clinic. Participants, aged 25 to 65 years with a BMI of 25 to 34.9, were assigned to receive either two 500 mg capsules of curcumin plus Amla (n = 25) or a placebo (n = 25) daily for 12 weeks. Results: Outcomes assessed changes in glycemic status, Hemoglobin A1c (HbA1c), inflammation, liver enzymes, oxidative stress, lipid profile, blood pressure, body measurements, quality of life, physical activity, and dietary intake. Conclusions: To ensure rigorous control, adherence was monitored through daily contact and three 24-hour food recalls at baseline and at the end of the trial. Only individuals with stable medication regimens for at least three months were included, with regular check-ins confirming no new medications affecting glycemic control or lipid profiles. Random assignment to the intervention or control group minimized bias, with the control group receiving placebo treatment for accurate comparison..