Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

Diabetes Mellitus,Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317211
• Other study ID #: ZXYZM-1
• Status: Completed
• Phase: Phase 0
• First received: December 7, 2014
• Last updated: November 16, 2015
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• 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

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 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)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 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
Extract of blueberry and huckleberry (MEDOX,http://www.medox.no/english)
• placebo
starch

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Shaoguan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control	Hemoglobin A1c (HbA1c),fasting blood glucose (FBG) at study entry and 12 weeks after dietary intervention	Twelve weeks	No
Secondary	Biomakers related to oxidative stress	Superoxide dismutase (SOD),Glutathione peroxidase (GSH-PX)	Twelve weeks	No
Secondary	Blood lipids	Cholesterol, HDL-cholesterol, Triglycerides	Twelve weeks	No