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NCT06057896 Clinical Trial

Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women

Metabolic Syndrome Clinical Trial

Official title:
Combined Natural Molecules Improve Markers of Metabolic Syndrome and Climacteric in Menopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06057896
Other study ID # Ins-SM-23
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2022
Est. completion date August 15, 2023

Study information
Verified date September 2023
Source Lo.Li.Pharma s.r.l
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study collected retrospective data from the assumption of combined natural molecules in menopausal women with metabolic syndrome

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 15, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years to 60 Years
Eligibility Inclusion Criteria: - menopause - diagnosis of metabolic syndrome Exclusion Criteria: - pharmacologically-induced menopause - hormonal therapies - sensitizing insulin therapies - cancer patient or ex-cancer patient

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• inositol, phytoestrogens, cocoa polyphenols
myo-inositol, soy isoflavones and cocoa polyphenols

Locations
Country Name City State
Italy SCCAL Naples

Sponsors (1)
Lead Sponsor Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body mass index Change of body weight [0, 6 months]
Secondary Climacteric Changes of number of flushes [0, 6 months]
Secondary Climateric Changes of intensity of flushes measured through questionnaire [0, 6 months]
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