Camelia Sinensis for Basal Metabolism and Body Composition

Postmenopausal Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031702
• Other study ID #: 0905/14122018
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: July 25, 2022

Study information

• Verified date: August 2021
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 25, 2022
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Postmenopausal Disorder

Intervention

Dietary Supplement:
• Camellia Sinensis leaf extract
2 tablets per day of 150 mg (1 before lunch and 1 before dinner)

Combination Product:
• Placebo
2 tablets per day of 150 mg (1 before lunch and 1 before dinner)

Locations

Country	Name	City	State
Italy	Mariangela Rondanelli	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes on energy expenditure	Basal metabolic rate (Kcal/day)	Changes from baseline energy expenditure at 4 and at 8 weeks
Primary	Changes on energy expenditure	24 h urinary nitrogen (g/24 h)	Changes from baseline energy expenditure at 4 and at 8 weeks
Secondary	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
Secondary	Changes on anthropometry	Weight (kg)	Changes from baseline anthropometry at 4 and at 8 weeks
Secondary	Changes on anthropometry	Body Mass Index (kg/m2)	Changes from baseline anthropometry at 4 and at 8 weeks
Secondary	Changes on anthropometry	Waist circumference (cm)	Changes from baseline anthropometry at 4 and at 8 weeks
Secondary	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
Secondary	Changes on carbohydrate profile	Glycemia (mg/dl)	Changes from baseline carbohydrate profile at 4 and at 8 weeks
Secondary	Changes on carbohydrate profile	Insulin (mcIU/ml)	Changes from baseline carbohydrate profile at 4 and at 8 weeks
Secondary	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
Secondary	Changes on inflammation	C-Reactive Protein (mg/dl)	Changes from baseline inflammation at 8 weeks
Secondary	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
Secondary	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
Secondary	Changes on citokine profile	Adiponectin (microg/ml)	Changes from baseline citokine profile at 4 and at 8 weeks
Secondary	Changes on citokine profile	Leptin (ng/ml)	Changes from baseline citokine profile at 4 and at 8 weeks
Secondary	Changes on plasma catecholamine profile	Adrenalin (ng/ml), Noradrenalin (ng/ml)	Changes from baseline plasma catecholamine profile at 4 and at 8 weeks
Secondary	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