Clinical trial NCT05031702: Camelia Sinensis for Basal Metabolism and Body Composition
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal Disorder
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 32
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Changes on energy expenditure
timeFrame: Changes from baseline energy expenditure at 4 and at 8 weeks
measure: Changes on energy expenditure
timeFrame: Changes from baseline energy expenditure at 4 and at 8 weeks
Secondary outcomes:
measure: Changes on body composition
timeFrame: Changes from baseline body composition at 4 and at 8 weeks
measure: Changes on anthropometry
timeFrame: Changes from baseline anthropometry at 4 and at 8 weeks
measure: Changes on anthropometry
timeFrame: Changes from baseline anthropometry at 4 and at 8 weeks
measure: Changes on anthropometry
timeFrame: Changes from baseline anthropometry at 4 and at 8 weeks
measure: Changes on insulin resistance
timeFrame: Changes from baseline insulin resistance at 4 and at 8 weeks
measure: Changes on carbohydrate profile
timeFrame: Changes from baseline carbohydrate profile at 4 and at 8 weeks
measure: Changes on carbohydrate profile
timeFrame: Changes from baseline carbohydrate profile at 4 and at 8 weeks
measure: Changes on lipid profile
timeFrame: Changes from baseline lipid profile at 8 weeks
measure: Changes on inflammation
timeFrame: Changes from baseline inflammation at 8 weeks
measure: Changes on incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks
measure: Changes on incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks
measure: Changes on citokine profile
timeFrame: Changes from baseline citokine profile at 4 and at 8 weeks
measure: Changes on citokine profile
timeFrame: Changes from baseline citokine profile at 4 and at 8 weeks
measure: Changes on plasma catecholamine profile
timeFrame: Changes from baseline plasma catecholamine profile at 4 and at 8 weeks
measure: Changes on satiety
timeFrame: Changes of satiety through 8 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Mariangela Rondanelli
Study officials:
References: