Clinical trial NCT02317211: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus，Type 2
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Shaoguan University
First posted: 2014-12-15
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Glycemic Control
timeFrame: Twelve weeks
Secondary outcomes:
measure: Biomakers related to oxidative stress
timeFrame: Twelve weeks
measure: Blood lipids
timeFrame: Twelve weeks
Other outcomes:
Locations:
Study officials:
affiliation: Guangdong Provincial Key Laboratory of Food, Nutrition and Health; Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)
name: Di Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.