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

Diabetes Mellitus,Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650726
• Other study ID #: ZXYZM-4
• Status: Completed
• Phase: Phase 0
• First received: January 5, 2016
• Last updated: January 7, 2016
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus,Type 2

Intervention

Dietary Supplement:
• Anthocyanin
anthocyanin 320 mg daily for 24 weeks

Other:
• Placebo
placebo 320mg daily for 24 weeks

Locations

Country	Name	City	State
China	Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes