Curcumin and Zinc Co-Supplementation Along With a Loss-Weight Diet Can Improve Lipid Profiles in Subjects with Pre-Diabetes: A Multi-Arm, Parallel-Group, Randomized, Double-Blind Placebo-Controlled Phase 2 Clinical Trial
Abstract Background: Diabetes is one of the major public health concerns. Pre-diabetes can increase the risk of developing some non-communicable diseases such as type 2 diabetes. Given the increasing trend of pre-diabetes, it is critical to control it and prevent its complications. Curcumin is a major bioactive component of turmeric. Zinc is an antioxidant nutrient. The present trial aimed to evaluate the effect of curcumin and zinc co-supplementation along with a loss-weight diet on serum lipid profiles in overweight or obese patients with pre-diabetes.Methods: Eighty-four participants were randomized to four groups (curcumin (500 mg/day), zinc (30 mg/day), “curcumin & zinc”, and placebo) for 90 days. Serum total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides (TG), non-HDL, HDL/LDL ratio, weight, BMI, waist circumstance (WC), hip circumstance (HC), physical activity (PA) and dietary intake were determined pre and post-intervention. This study will be conducted at Yazd Diabetes Research Clinic, Shahid Sadoughi University of Medical Sciences.Results: Totally, 82 participants were included in the final analysis. After the adjusted PA effect, changes in serum TG (adjusted p = 0.001), LDL (adjusted p = 0.035), non-HDL (adjusted p =0.003), HDL/LDL ratio (adjusted p =0.002), and HDL (adjusted p < 0.0001) revealed a significant difference between the groups. However, the changes in weight (adjusted p = 0.004) and BMI (adjusted p = 0.006) were significant but the changes in dietary intake, PA, WC, and HC were non-significant (adjusted p ≥ 0.05). Despite that there was a significant difference for post-intervention HDL levels (adjusted p = 0.016), other lipid profiles showed no significant difference (adjusted p ≥ 0.05).Conclusion: The beneficial effects of “curcumin & zinc” co-supplementation was reported for the changes of some lipid profiles (TG, LDL, HDL, non-HDL, and HDL to LDL ratio), BMI, and weight with no positive effects on TC, dietary intake, PA, WC, and HC. Therefore, it may play a potential role in the prevention of macro and microvascular complications.Trial registration: The project is a registered clinical trial (Registration number: IRCT20190902044671N1, Iranian Registry of Clinical Trials (IRCT), registered October 11, 2019.