Postmenopausal Disorder
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCamellia Sinensis leaf extract
2 tablets per day of 150 mg (1 before lunch and 1 before dinner)
COMBINATION_PRODUCTPlacebo
2 tablets per day of 150 mg (1 before lunch and 1 before dinner)
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Postmenopause * Overweight or obesity class I-II (Body Mass Index 25-39,9 Kg/m2)
Exclusion criteria
* Changes in heart rhythm * Intolerance or allergy to components * Obesity class III (Body Mass Index \> 40 Kg/m2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on energy expenditure | Changes from baseline energy expenditure at 4 and at 8 weeks | Basal metabolic rate (Kcal/day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on body composition | Changes from baseline body composition at 4 and at 8 weeks | Fat Free Mass (g), Fat Mass (g), Visceral Adipose Tissue (g) |
| Changes on anthropometry | Changes from baseline anthropometry at 4 and at 8 weeks | Weight (kg) |
| Changes on insulin resistance | Changes from baseline insulin resistance at 4 and at 8 weeks | Homeostasis Model Assessment (pt) for evaluate insulin resistance if \> 2,4 |
| Changes on carbohydrate profile | Changes from baseline carbohydrate profile at 4 and at 8 weeks | Glycemia (mg/dl) |
| Changes on inflammation | Changes from baseline inflammation at 8 weeks | C-Reactive Protein (mg/dl) |
| Changes on incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks | Alanine Aminotrasferase (IU/l), Aspartate Aminotrasferase (IU/I) |
| Changes on citokine profile | Changes from baseline citokine profile at 4 and at 8 weeks | Adiponectin (microg/ml) |
| Changes on plasma catecholamine profile | Changes from baseline plasma catecholamine profile at 4 and at 8 weeks | Adrenalin (ng/ml), Noradrenalin (ng/ml) |
| Changes on satiety | Changes of satiety through 8 weeks | Haber test (pt) for evaluation of satiety from 0 (no satiety) to 10 (a lot of satiety) |
| Changes on lipid profile | Changes from baseline lipid profile at 8 weeks | Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Tryglicerides (mg/dl) |
Countries
Italy
Outcome results
None listed