Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

• ClinicalTrials.gov Identifier: NCT02317211
• Recruitment Status: Completed
• First Posted: December 15, 2014
• Last Update Posted: November 17, 2015
• Sponsor: Sun Yat-sen University
• Collaborator: Shaoguan University
• Information provided by (Responsible Party): Di Li, Sun Yat-sen University

Tracking Information

• First Submitted Date: December 7, 2014
• First Posted Date: December 15, 2014
• Last Update Posted Date: November 17, 2015
• Study Start Date: February 2014
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus
• 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
• 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Diabetes Mellitus，Type 2

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 10, 2014): 70
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2014
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02317211
• Other Study ID Numbers: ZXYZM-1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Di Li, Sun Yat-sen University
• Original Responsible Party: Same as current
• Current Study Sponsor: Sun Yat-sen University
• Original Study Sponsor: Same as current
• 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)

• PRS Account: Sun Yat-sen University
• Verification Date: December 2014