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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | The participants in this group are instructed to consume placebo capsules every day during the trial period. |
|
| treatment group | Experimental | The participants in this group are instructed to consume anthocyanin capsules every day during the trial period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anthocyanin | Dietary Supplement | anthocyanin 320 mg daily for 24 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Di Li, PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus) | Guangzhou | Guangdong | 510080 | China |
It depends on the Sponsor Investigator
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000872 | Anthocyanins |
| ID | Term |
|---|---|
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Placebo | Other | placebo 320mg daily for 24 weeks |
|
| D004700 | Endocrine System Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |