Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

Early Phase 1

Completed

• Conditions: Diabetes Mellitus，Type 2
• Interventions: Dietary Supplement: Anthocyanin; Dietary Supplement: placebo

• Registration Number: NCT02317211
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Anthocyanins, the water-soluble compounds that make plants appear different colors, have been shown to prevent insulin resistance, reduce the blood glucose and oxidative stress in rodents. The purpose of our study is to evaluate a potential protective effect of purified anthocyanins supplement on type 2 diabetes mellitus patients.

Detailed Description

The study was designed as a randomized, double-blind label, interventional study on patients with T2DM. The eligible Participants are randomly assigned to control and Anthocyanins supplement group. During the 12 weeks trial period,the participants were instructed to consume two anthocyanin capsules or placebo capsules twice daily (30 min after breakfast and supper).

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-12
• Study First Submitted: 2014-12-07
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-15
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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)2h blood sugar after oral glucose tolerance test(OGTT)≥ 11.1
• Subject is between 25 and 75 years of age, inclusive.
• Subject 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 use exogenous insulin for glucose control.
• Subject that has a history of diabetic ketoacidosis.
• 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 supplementation with vitamins or antioxidants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anthocyanins treatment	Anthocyanin	anthocyanin supplement 320mg daily for twelve weeks
control	placebo	placebo 320 mg daily for twelve weeks

Primary Outcome Measures

Name	Time	Method
Glycemic Control	Twelve weeks	Hemoglobin A1c (HbA1c),fasting blood glucose (FBG) at study entry and 12 weeks after dietary intervention

Secondary Outcome Measures

Name	Time	Method
Biomakers related to oxidative stress	Twelve weeks	Superoxide dismutase (SOD),Glutathione peroxidase (GSH-PX)
Blood lipids	Twelve weeks	Cholesterol, HDL-cholesterol, Triglycerides