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Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus，Type 2 Dietary Supplement: Anthocyanin Dietary Supplement: placebo Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: control
placebo 320 mg daily for twelve weeks
 Dietary Supplement: placebo
starch
Other Name: 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 Name: natural purified anthocyanin


Outcome Measures
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Primary Outcome Measures :
  1. Glycemic Control [ Time Frame: Twelve weeks ]
    Hemoglobin A1c (HbA1c),fasting blood glucose (FBG) at study entry and 12 weeks after dietary intervention


Secondary Outcome Measures :
  1. Biomakers related to oxidative stress [ Time Frame: Twelve weeks ]
    Superoxide dismutase (SOD),Glutathione peroxidase (GSH-PX)

  2. Blood lipids [ Time Frame: Twelve weeks ]
    Cholesterol, HDL-cholesterol, Triglycerides


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317211


Sponsors and Collaborators
Sun Yat-sen University
Shaoguan University
Investigators
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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)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Di Li, PhD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02317211    
Other Study ID Numbers: ZXYZM-1
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases