Camelia Sinensis for Basal Metabolism and Body Composition

February 15, 2022 updated by: Azienda di Servizi alla Persona di Pavia

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes on energy expenditure
Time Frame: Changes from baseline energy expenditure at 4 and at 8 weeks
Basal metabolic rate (Kcal/day)
Changes from baseline energy expenditure at 4 and at 8 weeks
Changes on energy expenditure
Time Frame: Changes from baseline energy expenditure at 4 and at 8 weeks
24 h urinary nitrogen (g/24 h)
Changes from baseline energy expenditure at 4 and at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes on inflammation
Time Frame: Changes from baseline inflammation at 8 weeks
C-Reactive Protein (mg/dl)
Changes from baseline inflammation at 8 weeks
Changes on body composition
Time Frame: Changes from baseline body composition at 4 and at 8 weeks
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
Time Frame: Changes from baseline anthropometry at 4 and at 8 weeks
Weight (kg)
Changes from baseline anthropometry at 4 and at 8 weeks
Changes on anthropometry
Time Frame: Changes from baseline anthropometry at 4 and at 8 weeks
Body Mass Index (kg/m2)
Changes from baseline anthropometry at 4 and at 8 weeks
Changes on anthropometry
Time Frame: Changes from baseline anthropometry at 4 and at 8 weeks
Waist circumference (cm)
Changes from baseline anthropometry at 4 and at 8 weeks
Changes on insulin resistance
Time Frame: Changes from baseline insulin resistance at 4 and at 8 weeks
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
Time Frame: Changes from baseline carbohydrate profile at 4 and at 8 weeks
Glycemia (mg/dl)
Changes from baseline carbohydrate profile at 4 and at 8 weeks
Changes on carbohydrate profile
Time Frame: Changes from baseline carbohydrate profile at 4 and at 8 weeks
Insulin (mcIU/ml)
Changes from baseline carbohydrate profile at 4 and at 8 weeks
Changes on lipid profile
Time Frame: 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 from baseline lipid profile at 8 weeks
Changes on incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks
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]
Time Frame: Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks
Gamma Glutamyl Trasferase (U/l)
Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks
Changes on citokine profile
Time Frame: Changes from baseline citokine profile at 4 and at 8 weeks
Adiponectin (microg/ml)
Changes from baseline citokine profile at 4 and at 8 weeks
Changes on citokine profile
Time Frame: Changes from baseline citokine profile at 4 and at 8 weeks
Leptin (ng/ml)
Changes from baseline citokine profile at 4 and at 8 weeks
Changes on plasma catecholamine profile
Time Frame: Changes from baseline plasma catecholamine profile at 4 and at 8 weeks
Adrenalin (ng/ml), Noradrenalin (ng/ml)
Changes from baseline plasma catecholamine profile at 4 and at 8 weeks
Changes on satiety
Time Frame: Changes of satiety through 8 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda di Servizi alla Persona di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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