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

Arm | Intervention/treatment |
---|---|
Placebo Comparator: control
placebo 320 mg daily for twelve weeks
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Dietary Supplement: placebo
starch
Other Name: placebo capsule |
Experimental: anthocyanins treatment
anthocyanin supplement 320mg daily for twelve weeks
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Dietary Supplement: Anthocyanin
Extract of blueberry and huckleberry (MEDOX,http://www.medox.no/english)
Other Name: natural purified anthocyanin |
- Glycemic Control [ Time Frame: Twelve weeks ]Hemoglobin A1c (HbA1c),fasting blood glucose (FBG) at study entry and 12 weeks after dietary intervention
- 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

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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 |
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.

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
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) |
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 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |