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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Diabetes Mellitus，Type 2

Intervention / Treatment
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* Dietary Supplement: Anthocyanin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>The participants in this group are instructed to consume placebo capsules every day during the trial period. | Other: Placebo<br>* placebo 320mg daily for 24 weeks<br>|
| Experimental: treatment group<br>The participants in this group are instructed to consume anthocyanin capsules every day during the trial period. | Dietary Supplement: Anthocyanin<br>* anthocyanin 320 mg daily for 24 weeks<br>* Other names: MEDOX (natural purified anthocyanin);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL-associated PON1 activity | PON1 activity is assayed in HDL isolated from plasma of subjects from the placebo and anthocyanin groups by using UV spectrophotometry in a 96-well plate format using phenyl acetate or paraoxon as substrates. | 24 weeks | 
| The anti-oxidative ability of HDL | The anti-oxidative ability is assayed in HDL isolated from plasma of subjects from the placebo and anthocyanin groups by using fluorescence measurement in a 96-well plate format using dihydrorhodamine(DHR) as substrates. | 24 weeks | 
| anti-inflammatory ability of HDL | The ability of anti-inflammatory ability of HDL is showed as HDL inflammatory index (HII).HII means the ability of apolipoprotein (apo)B-depleted serum to inhibit or enhance the oxidation of LDL in the presence of a fluorescent organic phospholipid 2',7'-dichlorodihydrofluorescein diacetate (DCF) fluoresces substrate. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelium-dependent flow-mediated dilatation (FMD) | Endothelial function as determined by the flow-mediated dilatation (FMD) and endothelium-independent glyceryltrinitrate-induced dilation (GTND) were measured noninvasively in the right brachial artery by use of a high-resolution ultrasound scanning echo-tracking angiometer. | 24 weeks |