Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou 510080, China.
Department of Medical Statistics & Epidemiology, School of Public Health, Sun Yet-Sen University, Guangzhou 510080, China.
Nutrients. 2017 Oct 10;9(10):1104. doi: 10.3390/nu9101104.
In vitro and animal studies suggest that purified anthocyanins have favorable effects on metabolic profiles, but clinical trials have reported inconsistent findings. Furthermore, no study has been specifically conducted among individuals with prediabetes. The aim of this study was to investigate whether purified anthocyanins could improve cardiometabolic risk factors in Chinese adults with early untreated hyperglycemia. This was a 12-week randomized, double-blind, placebo-controlled trial. A total of 160 participants aged 40-75 years with prediabetes or early untreated diabetes were randomly allocated to receive either purified anthocyanins (320 mg/day, = 80) or placebo ( = 80) of identical appearance. A three-hour oral glucose tolerance test (OGTT) was performed, and cardiometabolic biomarkers (glycated hemoglobin A1c (HbA1c), fasting and postprandial glucose, insulin, C-peptide, and lipids) were measured at baseline and at the end of the trial. A total of 138 subjects completed the protocol. Compared with placebo, purified anthocyanins moderately reduced HbA1c (-0.14%, 95% CI: -0.23-0.04%; = 0.005), low-density lipoprotein-c (LDL-c) (-0.2 mmol/L, 95% CI: -0.38-0.01, = 0.04), apolipoprotein A-1 (apo A1) (0.09 g/L, 95% CI: 0.020.17; = 0.02), and apolipoprotein B (apo B) (-0.07 g/L, 95% CI: -0.13-0.01; = 0.01) according to intention-to-treat analysis. Subgroup analyses suggested that purified anthocyanins were more effective at improving glycemic control, insulin sensitivity, and lipids among patients with elevated metabolic markers. The 12-week randomized controlled trials (RCT) in Chinese adults with prediabetes or early untreated diabetes indicated that purified anthocyanins favorably affected glycemic control and lipid profile. Future studies of a longer duration that explore the dose-response relationship among patients with cardiometabolic disorders are needed to confirm our findings.
体外和动物研究表明，纯化的花青素对代谢谱有有利影响，但临床试验的结果并不一致。此外，尚无专门针对糖尿病前期人群的研究。本研究旨在探讨纯化的花青素是否可以改善中国早期未经治疗的高血糖成年人的心血管代谢危险因素。这是一项为期 12 周的随机、双盲、安慰剂对照试验。共有 160 名年龄在 40-75 岁之间的糖尿病前期或早期未经治疗的糖尿病患者被随机分配接受纯化的花青素（320mg/天，80 人）或安慰剂（80 人），两者外观相同。进行了三小时口服葡萄糖耐量试验（OGTT），并在基线和试验结束时测量了心血管代谢生物标志物（糖化血红蛋白 A1c（HbA1c）、空腹和餐后血糖、胰岛素、C 肽和血脂）。共有 138 名受试者完成了方案。与安慰剂相比，纯化的花青素适度降低了糖化血红蛋白 A1c（-0.14%，95%CI：-0.23-0.04%；=0.005）、低密度脂蛋白胆固醇（LDL-c）（-0.2mmol/L，95%CI：-0.38-0.01，=0.04）、载脂蛋白 A-1（apo A1）（0.09g/L，95%CI：0.020.17；=0.02）和载脂蛋白 B（apo B）（-0.07g/L，95%CI：-0.13-0.01；=0.01），根据意向治疗分析。亚组分析表明，纯化的花青素在改善代谢标志物升高的患者的血糖控制、胰岛素敏感性和血脂方面更有效。在中国糖尿病前期或早期未经治疗的糖尿病成年人中进行的为期 12 周的随机对照试验（RCT）表明，纯化的花青素对血糖控制和血脂谱有有利影响。需要进行更长时间的研究，以探索代谢紊乱患者中的剂量反应关系，从而证实我们的发现。
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