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Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02317211
Recruitment Status : Completed
First Posted : December 15, 2014
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
Shaoguan University
Information provided by (Responsible Party):
Di Li, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE December 7, 2014
First Posted Date  ICMJE December 15, 2014
Last Update Posted Date November 17, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
Glycemic Control [ Time Frame: Twelve weeks ]
Hemoglobin A1c (HbA1c),fasting blood glucose (FBG) at study entry and 12 weeks after dietary intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus
Official Title  ICMJE Effect of Purified Anthocyanin on Oxidative Stress and Glycemic Control in Subjects With Type 2 Diabetes Mellitus: A Randomized, Double-Blinded, Placebo-Controlled Trial
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus,Type 2
Intervention  ICMJE
  • Dietary Supplement: Anthocyanin
    Extract of blueberry and huckleberry (MEDOX,http://www.medox.no/english)
    Other Name: natural purified anthocyanin
  • Dietary Supplement: placebo
    starch
    Other Name: placebo capsule
Study Arms  ICMJE
  • Placebo Comparator: control
    placebo 320 mg daily for twelve weeks
    Intervention: Dietary Supplement: placebo
  • Experimental: anthocyanins treatment
    anthocyanin supplement 320mg daily for twelve weeks
    Intervention: Dietary Supplement: Anthocyanin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2014)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02317211
Other Study ID Numbers  ICMJE ZXYZM-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Di Li, Sun Yat-sen University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sun Yat-sen University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Shaoguan University
Investigators  ICMJE
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)
PRS Account Sun Yat-sen University
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP