Glucose Metabolism Disorders, Insulin Resistance, Lipid Metabolism Disorders, Type 2 Diabetes
Conditions
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTAnthocyanins
Anthocyanins capsules, which comprises different natural Anthocyanins purified from bilberries and blackcurrants
DIETARY_SUPPLEMENTPlacebo
Placebo capsules is identically packaged.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting glucose and HbA1C | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Total cholesterol,Triglycerides,HDL cholesterol,LDL cholesterol,Apolipoprotein A-I ,Apolipoprotein B |
| Calculated pancreatic β-cell function and insulin resistance | 12 weeks | — |
Countries
China
Outcome results
None listed