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

Study Overview
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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.

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

Conditions
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Insulin Resistance, Glucose Metabolism Disorders, Type 2 Diabetes, Lipid Metabolism Disorders

Intervention / Treatment
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* Dietary Supplement: Anthocyanins
* Dietary Supplement: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anthocyanins<br>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<br>* Anthocyanins capsules, which comprises different natural Anthocyanins purified from bilberries and blackcurrants<br>* Other names: Medox;|
| Placebo Comparator: Control<br>A daily intake of 320mg Placebo to instead of treatment of Anthocyanins. | Dietary Supplement: Placebo<br>* Placebo capsules is identically packaged.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting glucose and HbA1C |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the curves for Glucose,insulin and C peptide releasing test(fasting and post 75g oral glucose tolerance test) |  | 12 weeks | 
| Lipids | Total cholesterol,Triglycerides,HDL cholesterol,LDL cholesterol,Apolipoprotein A-I ,Apolipoprotein B | 12 weeks | 
| Calculated pancreatic β-cell function and insulin resistance |  | 12 weeks |