NCT02689765

Brief Summary

Metabolic problems represent one of the major health concerns which are attractive for being addressed by nutritional interventions, as these are directly connected to dietary habits.Anthocyans possess cardiovascular disease prevention, obesity control, and diabetes alleviation properties, but association between anthocyans and prediabetes need to be more firmly understood and established from robust clinical data. However, there is little human research that has reported on the efficacy of increased anthocyans bioactive consumption on insulin sensitivity in pre-diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_4

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

February 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

February 19, 2016

Last Update Submit

December 5, 2016

Conditions

Insulin ResistanceGlucose Metabolism DisordersType 2 DiabetesLipid Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

  • Change in fasting glucose and HbA1C

    12 weeks

Secondary Outcomes (3)

  • The area under the curves for Glucose,insulin and C peptide releasing test(fasting and post 75g oral glucose tolerance test)

    12 weeks

  • Lipids

    12 weeks

  • Calculated pancreatic β-cell function and insulin resistance

    12 weeks

Study Arms (2)

Anthocyanins

EXPERIMENTAL

Volunteers will be randomised double blinded into 'Anthocyanins' groups(n=60 per group)and given twice daily two capsules of either 80 grams of Anthocyanins, which corresponds a mixture of fresh blue berries and blackcurrants.The total duration of this trial was 24wk.

Dietary Supplement: Anthocyanins

Control

PLACEBO COMPARATOR

A daily intake of 320mg Placebo to instead of treatment of Anthocyanins.

Dietary Supplement: Placebo

Interventions

AnthocyaninsDIETARY_SUPPLEMENT

Anthocyanins capsules, which comprises different natural Anthocyanins purified from bilberries and blackcurrants

Also known as: Medox
Anthocyanins
PlaceboDIETARY_SUPPLEMENT

Placebo capsules is identically packaged.

Control

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) OR 2-h plasma glucose in the 75gOGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L)(IGT) OR HbA1C 5.7-6.4%.
  • Newly diagnosed T2DM who exceed the upper limit of the range but has not yet accepted hypoglycemic therapy.

You may not qualify if:

  • Patients with cardiac, renal, or hepatic diseases or with hyperthyroidism or who had concomitant infections, or who use of anti-diabetic drug or potential affect plasma glucose drugs, pregnant and breast-feeding women, and with polycystic ovarian syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baiyun Street Hospital,Yuexiu District

Guangzhou, Guangdong, 510100, China

Location

Related Publications (3)

  • Yang L, Liu Z, Ling W, Wang L, Wang C, Ma J, Peng X, Chen J. Effect of Anthocyanins Supplementation on Serum IGFBP-4 Fragments and Glycemic Control in Patients with Fasting Hyperglycemia: A Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2020 Sep 28;13:3395-3404. doi: 10.2147/DMSO.S266751. eCollection 2020.

    PMID: 33061500DERIVED

  • Yang L, Ling W, Qiu Y, Liu Y, Wang L, Yang J, Wang C, Ma J. Anthocyanins increase serum adiponectin in newly diagnosed diabetes but not in prediabetes: a randomized controlled trial. Nutr Metab (Lond). 2020 Sep 21;17:78. doi: 10.1186/s12986-020-00498-0. eCollection 2020.

    PMID: 32973912DERIVED

  • Yang L, Qiu Y, Ling W, Liu Z, Yang L, Wang C, Peng X, Wang L, Chen J. Anthocyanins regulate serum adipsin and visfatin in patients with prediabetes or newly diagnosed diabetes: a randomized controlled trial. Eur J Nutr. 2021 Jun;60(4):1935-1944. doi: 10.1007/s00394-020-02379-x. Epub 2020 Sep 15.

    PMID: 32930848DERIVED

Related Links

MeSH Terms

Conditions

Insulin ResistanceGlucose Metabolism DisordersDiabetes Mellitus, Type 2Lipid Metabolism Disorders

Interventions

Anthocyanins

Condition Hierarchy (Ancestors)

HyperinsulinismMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 19, 2016

First Posted

February 24, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

CN(1)