Curcumin and zinc co-supplementation along with a loss-weight diet can improve lipid profiles in subjects with prediabetes: a multi-arm, parallel-group, randomized, double-blind placebo-controlled phase 2 clinical trial

姜黄素和锌联合补充剂配合减重饮食可改善糖尿病前期患者的血脂谱:一项多臂、平行组、随机、双盲、安慰剂对照的 II 期临床试验

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Abstract

BACKGROUND: Diabetes is one of the major public health concerns. Prediabetes can increase the risk of developing some non-communicable diseases such as type 2 diabetes. Given the increasing trend of prediabetes, 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 prediabetes. METHODS: Eighty-four participants were randomized to four groups (curcumin (500 mg/day), zinc (30 mg/day), "curcumin and 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 and 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.

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