NCT02650726

Brief Summary

HDL function is impaired in patients with type 2 diabetes mellitus. Anthocyanin, a water-soluble compounds,is beneficial for vascular function by increasing nitric oxide (NO) bioavailability and decreasing oxidative stress. This study was designed to evaluate whether anthocyanin supplementation might improve cardiovascular function in diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Nov 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

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

November 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

January 5, 2016

Last Update Submit

January 7, 2016

Conditions

Diabetes Mellitus，Type 2

Outcome Measures

Primary Outcomes (3)

  • HDL-associated PON1 activity

    PON1 activity is assayed in HDL isolated from plasma of subjects from the placebo and anthocyanin groups by using UV spectrophotometry in a 96-well plate format using phenyl acetate or paraoxon as substrates.

    24 weeks

  • The anti-oxidative ability of HDL

    The anti-oxidative ability is assayed in HDL isolated from plasma of subjects from the placebo and anthocyanin groups by using fluorescence measurement in a 96-well plate format using dihydrorhodamine(DHR) as substrates.

    24 weeks

  • anti-inflammatory ability of HDL

    The ability of anti-inflammatory ability of HDL is showed as HDL inflammatory index (HII).HII means the ability of apolipoprotein (apo)B-depleted serum to inhibit or enhance the oxidation of LDL in the presence of a fluorescent organic phospholipid 2',7'-dichlorodihydrofluorescein diacetate (DCF) fluoresces substrate.

    24 weeks

Secondary Outcomes (1)

  • endothelium-dependent flow-mediated dilatation (FMD)

    24 weeks

Study Arms (2)

control group

PLACEBO COMPARATOR

The participants in this group are instructed to consume placebo capsules every day during the trial period.

Other: Placebo

treatment group

EXPERIMENTAL

The participants in this group are instructed to consume anthocyanin capsules every day during the trial period.

Dietary Supplement: Anthocyanin

Interventions

AnthocyaninDIETARY_SUPPLEMENT

anthocyanin 320 mg daily for 24 weeks

Also known as: MEDOX (natural purified anthocyanin)
treatment group
PlaceboOTHER

placebo 320mg daily for 24 weeks

control group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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) 2 h blood sugar after oral glucose tolerance test (OGTT) ≥11.1
  • Subject is between 40 and 60 years of age, inclusive
  • Subject's 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 is pregnant
  • 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 multivitamin supplement or other polyphenol supplement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510080, China

Location

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

    Sun Yat-sen University

    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

January 5, 2016

First Posted

January 8, 2016

Study Start

November 1, 2014

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

CN(1)