Camellia Sinensis leaf extract contributes to increasing energy expenditure and calorie consumption by increasing thermogenesis. The purpose of this study is to evaluate the efficacy of Camellia Sinensis on basal metabolism and body composition in overweight women or with obesity in postmenopause.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
2 tablets per day of 150 mg (1 before lunch and 1 before dinner)
2 tablets per day of 150 mg (1 before lunch and 1 before dinner)
Mariangela Rondanelli
Pavia, Italy
RECRUITINGChanges on energy expenditure
Basal metabolic rate (Kcal/day)
Time frame: Changes from baseline energy expenditure at 4 and at 8 weeks
Changes on energy expenditure
24 h urinary nitrogen (g/24 h)
Time frame: Changes from baseline energy expenditure at 4 and at 8 weeks
Changes on body composition
Fat Free Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)
Time frame: Changes from baseline body composition at 4 and at 8 weeks
Changes on anthropometry
Weight (kg)
Time frame: Changes from baseline anthropometry at 4 and at 8 weeks
Changes on anthropometry
Body Mass Index (kg/m2)
Time frame: Changes from baseline anthropometry at 4 and at 8 weeks
Changes on anthropometry
Waist circumference (cm)
Time frame: Changes from baseline anthropometry at 4 and at 8 weeks
Changes on insulin resistance
Homeostasis Model Assessment (pt) for evaluate insulin resistance if \> 2,4
Time frame: Changes from baseline insulin resistance at 4 and at 8 weeks
Changes on carbohydrate profile
Glycemia (mg/dl)
Time frame: Changes from baseline carbohydrate profile at 4 and at 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Changes on carbohydrate profile
Insulin (mcIU/ml)
Time frame: Changes from baseline carbohydrate profile at 4 and at 8 weeks
Changes on lipid profile
Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Tryglicerides (mg/dl)
Time frame: Changes from baseline lipid profile at 8 weeks
Changes on inflammation
C-Reactive Protein (mg/dl)
Time frame: Changes from baseline inflammation at 8 weeks
Changes on incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Alanine Aminotrasferase (IU/l), Aspartate Aminotrasferase (IU/I)
Time frame: Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks
Changes on incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Gamma Glutamyl Trasferase (U/l)
Time frame: Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks
Changes on citokine profile
Adiponectin (microg/ml)
Time frame: Changes from baseline citokine profile at 4 and at 8 weeks
Changes on citokine profile
Leptin (ng/ml)
Time frame: Changes from baseline citokine profile at 4 and at 8 weeks
Changes on plasma catecholamine profile
Adrenalin (ng/ml), Noradrenalin (ng/ml)
Time frame: Changes from baseline plasma catecholamine profile at 4 and at 8 weeks
Changes on satiety
Haber test (pt) for evaluation of satiety from 0 (no satiety) to 10 (a lot of satiety)
Time frame: Changes of satiety through 8 weeks