MenopauseNCT06057896
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
An observational study of Menopause and Climacteric Syndrome, run by Lo.Li.Pharma s.r.l at 1 site in Italy.
Trial summary
The study collected retrospective data from the assumption of combined natural molecules in menopausal women with metabolic syndrome Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Climacteric Syndrome, Metabolic Syndrome
- What is being tested?
- inositol, phytoestrogens, cocoa polyphenols
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2022to 15 Aug 2023
- Phase
- Observational
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women in menopause exhibiting at least three of the diagnostic criteria for metabolic syndrome
Who may be able to join
- menopause
- diagnosis of metabolic syndrome
Who cannot join
- pharmacologically-induced menopause
- hormonal therapies
- sensitizing insulin therapies
- cancer patient or ex-cancer patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Natural Molecules Improve Markers of Metabolic Syndrome and Climacteric in Menopausal Women
The study collected retrospective data from the assumption of combined natural molecules in menopausal women with metabolic syndrome
- Conditions
- Menopause, Climacteric Syndrome, Metabolic Syndrome
- Being tested
- inositol, phytoestrogens, cocoa polyphenols
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inositol, phytoestrogens, cocoa polyphenolsDietary supplement
myo-inositol, soy isoflavones and cocoa polyphenols
| Study group | Role | What they receive |
|---|---|---|
| inositol, phytoestrogens, cocoa polyphenols | Not described Receives: Dietary Supplement: inositol, phytoestrogens, cocoa polyphenols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Change of body weight
Measured: [0, 6 months]
Secondary outcomes (2)
Climacteric
Changes of number of flushes
Measured: [0, 6 months]
Climateric
Changes of intensity of flushes measured through questionnaire
Measured: [0, 6 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start30 Sep 2022
- Primary completion30 Jun 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lo.Li.Pharma s.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario Passaro, MD, Principal investigator, ASL NA3 Sud, Naples, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057896
- Sponsor's protocol ID
- Ins-SM-23
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Natural Molecules Improve Markers of Metabolic Syndrome and Climacteric in Menopausal Women
- ClinicalTrials.gov ID
- NCT06057896
- Acronym / sponsor ID
- Ins-SM-23
- Conditions
- Menopause, Climacteric Syndrome, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Lo.Li.Pharma s.r.lIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 28 Sep 2023 (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.
The study collected retrospective data from the assumption of combined natural molecules in menopausal women with metabolic syndrome
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inositol, phytoestrogens, cocoa polyphenols | – | Dietary Supplement: inositol, phytoestrogens, cocoa polyphenols |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women in menopause exhibiting at least three of the diagnostic criteria for metabolic syndrome
Key inclusion criteria (2 listed)
- menopause
- diagnosis of metabolic syndrome
Key exclusion criteria (4 listed)
- pharmacologically-induced menopause
- hormonal therapies
- sensitizing insulin therapies
- cancer patient or ex-cancer patient
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 |
|---|---|---|
| inositol, phytoestrogens, cocoa polyphenolsmyo-inositol, soy isoflavones and cocoa polyphenols | Dietary supplement | inositol, phytoestrogens, cocoa polyphenols |
Primary outcome
Body mass index
Time frame: [0, 6 months]
Change of body weight
2 secondary outcomes
Climacteric
Time frame: [0, 6 months]
Climateric
Time frame: [0, 6 months]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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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.
Mario Passaro, MD principal investigator
ASL NA3 Sud, Naples, Italy.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Climacteric Syndrome, run by Lo.Li.Pharma s.r.l 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 4 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: finished, as of the sponsor's last update on 8 Nov 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: [0, 6 months]). 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 8 Nov 2023.