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Effect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes

NCT ID: NCT02689765

Last Updated: 2016-12-06

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

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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The investigators plan to conduct a randomized double-blind, placebo-controlled trial to characterize the potential effects of anthocyans, purified from bilberries and blackcurrants, on metabolic abnormalities commonly associated with type 2 pre-diabetes.

Conditions

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Insulin Resistance Glucose Metabolism Disorders Type 2 Diabetes Lipid Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Anthocyanins

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.

Group Type EXPERIMENTAL

Anthocyanins

Intervention Type DIETARY_SUPPLEMENT

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

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo capsules is identically packaged.

Interventions

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Anthocyanins

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo capsules is identically packaged.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Medox

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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LiPing Yang

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Baiyun Street Hospital,Yuexiu District

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 33061500 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32973912 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32930848 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/?term=Purified+anthocyanin+supplementation+reduces+dyslipidemia%2C+enhances+antioxidant+capacity%2C+and+prevents+insulin+resistance+in+diabetic+patients

The effects of purified anthocyanins on dyslipidemia, oxidative status, and insulin sensitivity in patients with type 2 diabetes.

http://www.ncbi.nlm.nih.gov/pubmed/?term=A+CONSORT-compliant%2C+randomized%2C+double-blind%2C+placebo-controlled+pilot+trial+of+purified+anthocyanin+in+patients+with+nonalcoholic+fatty+liver+disease

The effects of anthocyanin supplementation on insulin resistance and liver injury biomarkers in patients with NAFLD.

http://www.ncbi.nlm.nih.gov/pubmed/?term=Anti-inflammatory+effect+of+purified+dietary+anthocyanin+in+adults+with+hypercholesterolemia%3A+a+randomized+controlled+trial

The supplementation of an anthocyanin mixture to hypercholesterolemic subjects for 24 weeks reduced serum levels of CRP, VCAM-1 and IL-1b, which involved the improvement of the lipid profile

Other Identifiers

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20151218

Identifier Type: -

Identifier Source: org_study_id