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Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06057896
Recruitment Status : Completed
First Posted : September 28, 2023
Last Update Posted : November 8, 2023
Sponsor:
Information provided by (Responsible Party):
Lo.Li.Pharma s.r.l

Study Description
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Brief Summary:
The study collected retrospective data from the assumption of combined natural molecules in menopausal women with metabolic syndrome

Condition or disease Intervention/treatment
Menopause Climacteric Syndrome Metabolic Syndrome Dietary Supplement: inositol, phytoestrogens, cocoa polyphenols

Study Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Combined Natural Molecules Improve Markers of Metabolic Syndrome and Climacteric in Menopausal Women
Actual Study Start Date : September 30, 2022
Actual Primary Completion Date : June 30, 2023
Actual Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Groups and Cohorts
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Group/Cohort Intervention/treatment
inositol, phytoestrogens, cocoa polyphenols Dietary Supplement: inositol, phytoestrogens, cocoa polyphenols
myo-inositol, soy isoflavones and cocoa polyphenols


Outcome Measures
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Primary Outcome Measures :
  1. Body mass index [ Time Frame: [0, 6 months] ]
    Change of body weight


Secondary Outcome Measures :
  1. Climacteric [ Time Frame: [0, 6 months] ]
    Changes of number of flushes

  2. Climateric [ Time Frame: [0, 6 months] ]
    Changes of intensity of flushes measured through questionnaire


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
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
Criteria

Inclusion Criteria:

  • menopause
  • diagnosis of metabolic syndrome

Exclusion Criteria:

  • pharmacologically-induced menopause
  • hormonal therapies
  • sensitizing insulin therapies
  • cancer patient or ex-cancer patient
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06057896


Locations
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Italy
SCCAL
Naples, Italy
Sponsors and Collaborators
Lo.Li.Pharma s.r.l
Investigators
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Principal Investigator: Mario Passaro, MD ASL NA3 Sud, Naples, Italy.
More Information
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Responsible Party: Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier: NCT06057896    
Other Study ID Numbers: Ins-SM-23
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: November 8, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Inositol
 Phytoestrogens
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists