Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

Sun Yat-sen University

Status and phase: Completed; Early Phase 1

Conditions: Diabetes Mellitus，Type 2

Treatments: Dietary Supplement: placebo; Dietary Supplement: Anthocyanin

Study type: Interventional

Funder types: Other

Identifiers

NCT02317211

ZXYZM-1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 70 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

placebo 320 mg daily for twelve weeks

Treatment:

Dietary Supplement: placebo

anthocyanins treatment

Experimental group

Description:

anthocyanin supplement 320mg daily for twelve weeks

Treatment:

Dietary Supplement: Anthocyanin