Purified Anthocyanins Supplementation and High-Density Lipoprotein (HDL) Function

Effect of Purification Anthocyanins on HDL and Endothelial Function in Subjects With Type 2 Diabetes Mellitus: A Randomized, Double-Blinded, Placebo-Controlled Trial

HDL function is impaired in patients with type 2 diabetes mellitus. Anthocyanin, a water-soluble compounds,is beneficial for vascular function by increasing nitric oxide (NO) bioavailability and decreasing oxidative stress. This study was designed to evaluate whether anthocyanin supplementation might improve cardiovascular function in diabetic patients.

The study is designed as a randomized, double-blind label, interventional study on patients with T2DM. The eligible participants are randomly assigned to control and anthocyanins group. During the 24 weeks trial period, the participants are instructed to consume two anthocyanin capsules or placebo capsules twice daily (30 minutes after breakfast and supper).

Inclusion Criteria:

• Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows: (1) Diabetes symptoms（polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar）combined with random blood sugar ≥11.1 OR, (2) fasting plasma glucose (FPG) ≥7.0 OR, (3) 2 h blood sugar after oral glucose tolerance test (OGTT) ≥11.1
• Subject is between 40 and 60 years of age, inclusive
• Subject's BMI is >18.5 kg/m2 and <35 kg/m2.

Exclusion Criteria:

• Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2
• Subject that is pregnant
• Subject that has coronary artery disease, mental disorder, cancer, cirrhosis, renal disease and hepatic disease
• Subject that has had operation less than six months prior to screening visit
• Subject that uses multivitamin supplement or other polyphenol supplement