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NCT Number: NCT02689765

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

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.

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Key information

Conditions

Insulin Resistance Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baiyun Street Hospital,Yuexiu District

Guangzhou, Guangdong, 510100, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

anthocyanins

Dietary Supplement

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

Other names: Medox

Placebo

Dietary Supplement

Placebo capsules is identically packaged.

Primary outcomes

  1. Change in fasting glucose and HbA1C

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: 12 weeks

  2. Lipids

    Time frame: 12 weeks

    Total cholesterol,Triglycerides,HDL cholesterol,LDL cholesterol,Apolipoprotein A-I ,Apolipoprotein B

  3. Calculated pancreatic β-cell function and insulin resistance

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Effect of Anthocyanins on Metabolic Profiles in Subjects With Pre-diabetes: A Randomized, Double-blind, Placebo-controlled Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 24, 2016
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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