Camelia Sinensis for Basal Metabolism and Body Composition

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postmenopausal Disorder
• Intervention / Treatment: Dietary supplement: Camellia Sinensis leaf extract; Combination product: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Mariangela Rondanelli
    • Contact: Mariangela Rondanelli; Phone Number: 0382381739; Email: mariangela.rondanelli@unipv.it
    • Contact: Mariangela Rondanelli; Phone Number: Rondanelli +390382381739; Email: mariangela.rondanelli@unipv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 inflammation	C-Reactive Protein (mg/dl)	Changes from baseline inflammation at 8 weeks
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 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

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): January 3, 2022
• Study Completion (Anticipated): July 25, 2022

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: August 27, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 0905/14122018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No