Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

Effect of Purified Anthocyanin on Oxidative Stress and Glycemic Control in Subjects With Type 2 Diabetes Mellitus: A Randomized, Double-Blinded, Placebo-Controlled Trial

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02317211

Enrollment

Registered

2014-12-15

Start date

2014-02-28

Completion date

2014-09-30

Last updated

2015-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus，Type 2

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).

Interventions

DIETARY_SUPPLEMENTAnthocyanin

Extract of blueberry and huckleberry （MEDOX，http://www.medox.no/english）

DIETARY_SUPPLEMENTplacebo

starch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Glycemic Control	Twelve weeks	Hemoglobin A1c (HbA1c),fasting blood glucose (FBG) at study entry and 12 weeks after dietary intervention

Secondary

Measure	Time frame	Description
Biomakers related to oxidative stress	Twelve weeks	Superoxide dismutase (SOD),Glutathione peroxidase (GSH-PX)
Blood lipids	Twelve weeks	Cholesterol, HDL-cholesterol, Triglycerides

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026