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

Sun Yat-sen University

Status and phase: Completed; Early Phase 1

Conditions: Diabetes Mellitus，Type 2

Treatments: Dietary Supplement: Anthocyanin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02650726

ZXYZM-4

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 80 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

The participants in this group are instructed to consume placebo capsules every day during the trial period.

Treatment:

Other: Placebo

treatment group

Experimental group

Description:

The participants in this group are instructed to consume anthocyanin capsules every day during the trial period.

Treatment:

Dietary Supplement: Anthocyanin