Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2014

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).

Interventions

  • Dietary Supplement: Anthocyanin
    • Extract of blueberry and huckleberry (MEDOX,http://www.medox.no/english)
  • Dietary Supplement: placebo
    • starch

Arms, Groups and Cohorts

  • Placebo Comparator: control
    • placebo 320 mg daily for twelve weeks
  • Experimental: anthocyanins treatment
    • anthocyanin supplement 320mg daily for twelve weeks

Clinical Trial Outcome Measures

Primary Measures

  • Glycemic Control
    • Time Frame: Twelve weeks
    • Hemoglobin A1c (HbA1c),fasting blood glucose (FBG) at study entry and 12 weeks after dietary intervention

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Collaborator
    • Shaoguan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Di Li, PhD – Sun Yat-sen University
  • Overall Official(s)
    • Di Li, PhD, Principal Investigator, Guangdong Provincial Key Laboratory of Food, Nutrition and Health; Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.