Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women

November 7, 2023 updated by: Lo.Li.Pharma s.r.l

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

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

  • Italy
      • Naples, Italy
        • SCCAL

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women in menopause exhibiting at least three of the diagnostic criteria for metabolic syndrome

Description

Inclusion Criteria:

  • menopause
  • diagnosis of metabolic syndrome

Exclusion Criteria:

  • pharmacologically-induced menopause
  • hormonal therapies
  • sensitizing insulin therapies
  • cancer patient or ex-cancer patient

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
inositol, phytoestrogens, cocoa polyphenols
Dietary supplement: inositol, phytoestrogens, cocoa polyphenols
myo-inositol, soy isoflavones and cocoa polyphenols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: [0, 6 months]
Change of body weight
[0, 6 months]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Climacteric
Time Frame: [0, 6 months]
Changes of number of flushes
[0, 6 months]
Climateric
Time Frame: [0, 6 months]
Changes of intensity of flushes measured through questionnaire
[0, 6 months]

Collaborators and Investigators

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

Sponsor

Lo.Li.Pharma s.r.l

Investigators

  • Principal Investigator: Mario Passaro, MD, ASL NA3 Sud, Naples, Italy.

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)

September 30, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ins-SM-23

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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