Camelia Sinensis for Basal Metabolism and Body Composition

Not Applicable

• Conditions: Postmenopausal Disorder
• Interventions: Combination Product: Placebo; Dietary Supplement: Camellia Sinensis leaf extract

• Registration Number: NCT05031702
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-08
• Status Verified: 2021-08
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-09-02
• Primary Completion: 2022-01-03
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03
• Study Completion: 2022-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 32

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Tablets of the same size as the active component
Dietary supplement	Camellia Sinensis leaf extract	Extract from Camellia Sinensis leaf

Primary Outcome Measures

Name	Time	Method
Changes on energy expenditure	Changes from baseline energy expenditure at 4 and at 8 weeks	24 h urinary nitrogen (g/24 h)

Secondary Outcome Measures

Name	Time	Method
Changes on inflammation	Changes from baseline inflammation at 8 weeks	C-Reactive Protein (mg/dl)
Changes on citokine profile	Changes from baseline citokine profile at 4 and at 8 weeks	Leptin (ng/ml)
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	Waist circumference (cm)
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 incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks	Gamma Glutamyl Trasferase (U/l)
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 carbohydrate profile	Changes from baseline carbohydrate profile at 4 and at 8 weeks	Insulin (mcIU/ml)
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)
Changes on plasma catecholamine profile	Changes from baseline plasma catecholamine profile at 4 and at 8 weeks	Adrenalin (ng/ml), Noradrenalin (ng/ml)

Trial Locations

Locations (1)

Mariangela Rondanelli; 🇮🇹 Pavia, Italy