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OpenTrials
Completed

NCT Number: NCT06057896

Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women

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

Completed

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Key information

Conditions

Menopause Climacteric Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

45 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

SCCAL

Naples, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • menopause
  • diagnosis of metabolic syndrome

Exclusion criteria

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

Treatment and study plan

inositol, phytoestrogens, cocoa polyphenols

Dietary Supplement

myo-inositol, soy isoflavones and cocoa polyphenols

Primary outcomes

  1. Body mass index

    Time frame: [0, 6 months]

    Change of body weight

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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