Postmenopausal DisorderNCT05031702
Camelia Sinensis for Basal Metabolism and Body Composition
A study testing Camellia Sinensis leaf extract in people with Postmenopausal Disorder, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Disorder
- What is being tested?
- Camellia Sinensis leaf extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 8 Mar 2021to 25 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopause
- Overweight or obesity class I-II (Body Mass Index 25-39,9 Kg/m2)
Who cannot join
- Changes in heart rhythm
- Intolerance or allergy to components
- Obesity class III (Body Mass Index > 40 Kg/m2)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Mariangela Rondanelli
Pavia, 27100
Mariangela Rondanelli, 0382381739, mariangela.rondanelli@unipv.it
Mariangela Rondanelli, +390382381739 ext. Rondanelli, mariangela.rondanelli@unipv.it
About this study
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
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.
- Conditions
- Postmenopausal Disorder
- Being tested
- Camellia Sinensis leaf extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camellia Sinensis leaf extractDietary supplement
2 tablets per day of 150 mg (1 before lunch and 1 before dinner)
PlaceboCombination product
2 tablets per day of 150 mg (1 before lunch and 1 before dinner)
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement | Active comparator | Extract from Camellia Sinensis leaf Receives: Dietary Supplement: Camellia Sinensis leaf extract |
| Placebo | Placebo comparator | Tablets of the same size as the active component Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on energy expenditure
Basal metabolic rate (Kcal/day)
Measured: Changes from baseline energy expenditure at 4 and at 8 weeks
Changes on energy expenditure
24 h urinary nitrogen (g/24 h)
Measured: Changes from baseline energy expenditure at 4 and at 8 weeks
Secondary outcomes (15)
Changes on body composition
Fat Free Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)
Measured: Changes from baseline body composition at 4 and at 8 weeks
Changes on anthropometry
Weight (kg)
Measured: Changes from baseline anthropometry at 4 and at 8 weeks
Changes on anthropometry
Body Mass Index (kg/m2)
Measured: Changes from baseline anthropometry at 4 and at 8 weeks
Changes on anthropometry
Waist circumference (cm)
Measured: 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
Measured: Changes from baseline insulin resistance at 4 and at 8 weeks
Changes on carbohydrate profile
Glycemia (mg/dl)
Measured: Changes from baseline carbohydrate profile at 4 and at 8 weeks
Changes on carbohydrate profile
Insulin (mcIU/ml)
Measured: 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)
Measured: Changes from baseline lipid profile at 8 weeks
Changes on inflammation
C-Reactive Protein (mg/dl)
Measured: Changes from baseline inflammation at 8 weeks
Changes on incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Alanine Aminotrasferase (IU/l), Aspartate Aminotrasferase (IU/I)
Measured: 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)
Measured: Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks
Changes on citokine profile
Adiponectin (microg/ml)
Measured: Changes from baseline citokine profile at 4 and at 8 weeks
Changes on citokine profile
Leptin (ng/ml)
Measured: Changes from baseline citokine profile at 4 and at 8 weeks
Changes on plasma catecholamine profile
Adrenalin (ng/ml), Noradrenalin (ng/ml)
Measured: 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)
Measured: Changes of satiety through 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start8 Mar 2021
- Primary completion3 Jan 2022
- Study completion25 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031702
- Sponsor's protocol ID
- 0905/14122018
- Status last verified
- Aug 2021
- First submitted
- 27 Aug 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05031702
- Acronym / sponsor ID
- 0905/14122018
- Conditions
- Postmenopausal Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 25 Jul 2022 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Active comparator | Dietary Supplement: Camellia Sinensis leaf extractExtract from Camellia Sinensis leaf |
| Placebo | Placebo comparator | Combination Product: PlaceboTablets of the same size as the active component |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopause
- Overweight or obesity class I-II (Body Mass Index 25-39,9 Kg/m2)
Key exclusion criteria (3 listed)
- Changes in heart rhythm
- Intolerance or allergy to components
- Obesity class III (Body Mass Index > 40 Kg/m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camellia Sinensis leaf extract2 tablets per day of 150 mg (1 before lunch and 1 before dinner) | Dietary supplement | Dietary supplement |
| Placebo2 tablets per day of 150 mg (1 before lunch and 1 before dinner) | Combination product | Placebo |
Primary outcome
Changes on energy expenditure
Time frame: Changes from baseline energy expenditure at 4 and at 8 weeks
Basal metabolic rate (Kcal/day)
Changes on energy expenditure
Time frame: Changes from baseline energy expenditure at 4 and at 8 weeks
24 h urinary nitrogen (g/24 h)
15 secondary outcomes
Changes on body composition
Time frame: 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
Changes on anthropometry
Time frame: 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
Changes on insulin resistance
Time frame: 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
Changes on carbohydrate profile
Time frame: 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
Changes on inflammation
Time frame: Changes from baseline inflammation 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
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
Changes on citokine profile
Time frame: 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
Changes on plasma catecholamine profile
Time frame: Changes from baseline plasma catecholamine profile at 4 and at 8 weeks
Changes on satiety
Time frame: Changes of satiety through 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camellia Sinensis leaf extract in people with Postmenopausal Disorder, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on energy expenditure (time frame: Changes from baseline energy expenditure at 4 and at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.