Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus，Type 2
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: Anthocyanin

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; placebo 320 mg daily for twelve weeks	Dietary supplement: placebo; starch; Other Names: placebo capsule
Experimental: anthocyanins treatment; anthocyanin supplement 320mg daily for twelve weeks	Dietary supplement: Anthocyanin; Extract of blueberry and huckleberry （MEDOX，http://www.medox.no/english）; 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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Shaoguan University
• Investigators: Principal Investigator: Di Li, PhD, Guangdong Provincial Key Laboratory of Food, Nutrition and Health; Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)

Publications and helpful links

General Publications

• Li D, Zhang Y, Liu Y, Sun R, Xia M. Purified anthocyanin supplementation reduces dyslipidemia, enhances antioxidant capacity, and prevents insulin resistance in diabetic patients. J Nutr. 2015 Apr;145(4):742-8. doi: 10.3945/jn.114.205674. Epub 2015 Feb 4.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: December 7, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ZXYZM-1