Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

Study Overview
=================
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).

Official Title
-----------------
Effect of Purified Anthocyanin on Oxidative Stress and Glycemic Control in Subjects With Type 2 Diabetes Mellitus: A Randomized, Double-Blinded, Placebo-Controlled Trial

Conditions
-----------------
Diabetes Mellitus，Type 2

Intervention / Treatment
-----------------
* Dietary Supplement: Anthocyanin
* Dietary Supplement: placebo


Participation Criteria
=================
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)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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>placebo 320 mg daily for twelve weeks | Dietary Supplement: placebo<br>* starch<br>* Other names: placebo capsule;|
| Experimental: anthocyanins treatment<br>anthocyanin supplement 320mg daily for twelve weeks | Dietary Supplement: Anthocyanin<br>* Extract of blueberry and huckleberry （MEDOX，http://www.medox.no/english）<br>* Other names: natural purified anthocyanin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control | Hemoglobin A1c (HbA1c),fasting blood glucose (FBG) at study entry and 12 weeks after dietary intervention | Twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomakers related to oxidative stress | Superoxide dismutase (SOD),Glutathione peroxidase (GSH-PX) | Twelve weeks | 
| Blood lipids | Cholesterol, HDL-cholesterol, Triglycerides | Twelve weeks |