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

NCT ID: NCT02650726

Last Updated: 2016-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-11-30

Brief Summary

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.

Detailed 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).

Conditions

Diabetes Mellitus，Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo 320mg daily for 24 weeks

treatment group

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

Group Type: EXPERIMENTAL

Anthocyanin

Intervention Type: DIETARY_SUPPLEMENT

anthocyanin 320 mg daily for 24 weeks

Interventions

Anthocyanin

anthocyanin 320 mg daily for 24 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

placebo 320mg daily for 24 weeks

Intervention Type: OTHER

Other Intervention Names

MEDOX (natural purified anthocyanin)

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Di Li

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Di Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ZXYZM-4

Identifier Type: -

Identifier Source: org_study_id