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Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus

NCT ID: NCT02317211

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-09-30

Brief Summary

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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

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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).

Conditions

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Diabetes Mellitus，Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control

placebo 320 mg daily for twelve weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

starch

anthocyanins treatment

anthocyanin supplement 320mg daily for twelve weeks

Group Type EXPERIMENTAL

Anthocyanin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Anthocyanin

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

Intervention Type DIETARY_SUPPLEMENT

placebo

starch

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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natural purified anthocyanin placebo capsule

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaoguan University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Di Li

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Di Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial Key Laboratory of Food, Nutrition and Health; Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)

References

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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.

Reference Type DERIVED
PMID: 25833778 (View on PubMed)

Other Identifiers

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ZXYZM-1

Identifier Type: -

Identifier Source: org_study_id