NCT02317211

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2014

Shorter than P25 for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
Last Updated

November 17, 2015

Status Verified

December 1, 2014

Enrollment Period

7 months

First QC Date

December 7, 2014

Last Update Submit

November 16, 2015

Conditions

Diabetes Mellitus，Type 2

Outcome Measures

Primary Outcomes (1)

  • Glycemic Control

    Hemoglobin A1c (HbA1c),fasting blood glucose (FBG) at study entry and 12 weeks after dietary intervention

    Twelve weeks

Secondary Outcomes (2)

  • Biomakers related to oxidative stress

    Twelve weeks

  • Blood lipids

    Twelve weeks

Study Arms (2)

control

PLACEBO COMPARATOR

placebo 320 mg daily for twelve weeks

Dietary Supplement: placebo

anthocyanins treatment

EXPERIMENTAL

anthocyanin supplement 320mg daily for twelve weeks

Dietary Supplement: Anthocyanin

Interventions

AnthocyaninDIETARY_SUPPLEMENT

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

Also known as: natural purified anthocyanin
anthocyanins treatment
placeboDIETARY_SUPPLEMENT

starch

Also known as: placebo capsule
control

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25833778DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Anthocyanins

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlycosidesCarbohydratesPigments, BiologicalBiological Factors

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 7, 2014

First Posted

December 15, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 17, 2015

Record last verified: 2014-12