The aim of the study was to evaluate the effectiveness of a food supplement, berberine phytosome, which contributes to the control of blood sugar and the improvement of insulin resistance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
2 tablets of 550 mg per day (1 before lunch and 1 before dinner)
Mariangela Rondanelli
Pavia, Italy
RECRUITINGChanges on insulin resistance
Homeostasis Model Assessment (pt), for evaluate insulin resistance if \> 2,4
Time frame: Changes from baseline insulin resistance at 4 weeks and at 8 weeks
Changes on carbohydrate profile
Fasting Glucose (mg/dl)
Time frame: Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Changes on carbohydrate profile
Glycated hemoglobin (%)
Time frame: Changes from baseline carbohydrate profile at 4 weeks and at 8 weeks
Changes on anthropometry
Weight (Kg)
Time frame: Changes from baseline anthropometry at 4 weeks and at 8 weeks
Changes on anthropometry
Body Mass Index (Kg/m2)
Time frame: Changes from baseline anthropometry at 4 weeks and at 8 weeks
Changes on anthropometry
Waist circumference (cm)
Time frame: Changes from baseline anthropometry at 4 weeks and at 8 weeks
Changes on body composition
Fat mass (g), Fat Free Mass (g), Visceral Adipose Tissue (g)
Time frame: Changes from baseline body composition at 4 weeks and at 8 weeks
Changes on lipid profile
Total Cholesterol (mg/dl), High density lipoprotein Cholesterol (mg/dl), Low density lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl), Apolipoprotein A (mg/dl), Apolipoprotein B (mg/dl)
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Time frame: Changes from baseline lipid profile at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Alanine aminotransferase (IU/l), Aspartate aminotransferase (IU/l)
Time frame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Gamma Glutamyl Transferase (U/l)
Time frame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Creatinine (mg/dl)
Time frame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks
Changes on Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Glomerural Filtrate Rate (ml/min)
Time frame: Changes from baseline Incidence of Treatment-Emergent Adverse Events at 4 weeks and at 8 weeks