Camelia Sinensis for Basal Metabolism and Body Composition

• Sponsor: Azienda di Servizi alla Persona di Pavia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05031702
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16.6
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Disorder	Dietary Supplement: Camellia Sinensis leaf extract; Combination Product: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 8, 2021
• Actual Primary Completion Date: Jan 3, 2022
• Anticipated Study Completion Date: Jul 25, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Changes on energy expenditure [Changes from baseline energy expenditure at 4 and at 8 weeks]

   Basal metabolic rate (Kcal/day)

2. 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

1. 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)

2. Changes on anthropometry [Changes from baseline anthropometry at 4 and at 8 weeks]

   Weight (kg)

3. Changes on anthropometry [Changes from baseline anthropometry at 4 and at 8 weeks]

   Body Mass Index (kg/m2)

4. Changes on anthropometry [Changes from baseline anthropometry at 4 and at 8 weeks]

   Waist circumference (cm)

5. 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

6. Changes on carbohydrate profile [Changes from baseline carbohydrate profile at 4 and at 8 weeks]

   Glycemia (mg/dl)

7. Changes on carbohydrate profile [Changes from baseline carbohydrate profile at 4 and at 8 weeks]

   Insulin (mcIU/ml)

8. 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)

9. Changes on inflammation [Changes from baseline inflammation at 8 weeks]

   C-Reactive Protein (mg/dl)

10. Changes on incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks]

    Alanine Aminotrasferase (IU/l), Aspartate Aminotrasferase (IU/I)

11. 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)

12. Changes on citokine profile [Changes from baseline citokine profile at 4 and at 8 weeks]

    Adiponectin (microg/ml)

13. Changes on citokine profile [Changes from baseline citokine profile at 4 and at 8 weeks]

    Leptin (ng/ml)

14. Changes on plasma catecholamine profile [Changes from baseline plasma catecholamine profile at 4 and at 8 weeks]

    Adrenalin (ng/ml), Noradrenalin (ng/ml)

15. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mariangela Rondanelli	Pavia		Italy	27100

Sponsors and Collaborators

• Azienda di Servizi alla Persona di Pavia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Azienda di Servizi alla Persona di Pavia
• ClinicalTrials.gov Identifier: NCT05031702
• Other Study ID Numbers: 0905/14122018
• First Posted: Sep 2, 2021
• Last Update Posted: Mar 3, 2022
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 3, 2022