Camelia Sinensis for Basal Metabolism and Body Composition

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of the Assumption of a Supplement Based on the Extract From Camelia Leaf Sinensis on Basal Metabolism and Body Composition in Overweight Women or With Obesity in Postmenopause

Conditions
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Postmenopausal Disorder

Intervention / Treatment
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* Dietary Supplement: Camellia Sinensis leaf extract
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary supplement<br>Extract from Camellia Sinensis leaf | Dietary Supplement: Camellia Sinensis leaf extract<br>* 2 tablets per day of 150 mg (1 before lunch and 1 before dinner)<br>|
| Placebo Comparator: Placebo<br>Tablets of the same size as the active component | Combination Product: Placebo<br>* 2 tablets per day of 150 mg (1 before lunch and 1 before dinner)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on energy expenditure | Basal metabolic rate (Kcal/day) | Changes from baseline energy expenditure at 4 and at 8 weeks | 
| Changes on energy expenditure | 24 h urinary nitrogen (g/24 h) | Changes from baseline energy expenditure at 4 and at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on body composition | Fat Free Mass (g), Fat Mass (g), Visceral Adipose Tissue (g) | Changes from baseline body composition at 4 and at 8 weeks | 
| Changes on anthropometry | Weight (kg) | Changes from baseline anthropometry at 4 and at 8 weeks | 
| Changes on anthropometry | Body Mass Index (kg/m2) | Changes from baseline anthropometry at 4 and at 8 weeks | 
| Changes on anthropometry | Waist circumference (cm) | 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 | Changes from baseline insulin resistance at 4 and at 8 weeks | 
| Changes on carbohydrate profile | Glycemia (mg/dl) | Changes from baseline carbohydrate profile at 4 and at 8 weeks | 
| Changes on carbohydrate profile | Insulin (mcIU/ml) | 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) | Changes from baseline lipid profile at 8 weeks | 
| Changes on inflammation | C-Reactive Protein (mg/dl) | 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) | 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) | Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks | 
| Changes on citokine profile | Adiponectin (microg/ml) | Changes from baseline citokine profile at 4 and at 8 weeks | 
| Changes on citokine profile | Leptin (ng/ml) | Changes from baseline citokine profile at 4 and at 8 weeks | 
| Changes on plasma catecholamine profile | Adrenalin (ng/ml), Noradrenalin (ng/ml) | 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) | Changes of satiety through 8 weeks |