NCT06057896

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

November 8, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 21, 2023

Last Update Submit

November 7, 2023

Conditions

MenopauseClimacteric SyndromeMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Body mass index

    Change of body weight

    [0, 6 months]

Secondary Outcomes (2)

  • Climacteric

    [0, 6 months]

  • Climateric

    [0, 6 months]

Study Arms (1)

inositol, phytoestrogens, cocoa polyphenols

Dietary Supplement: inositol, phytoestrogens, cocoa polyphenols

Interventions

inositol, phytoestrogens, cocoa polyphenolsDIETARY_SUPPLEMENT

myo-inositol, soy isoflavones and cocoa polyphenols

inositol, phytoestrogens, cocoa polyphenols

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • menopause
  • diagnosis of metabolic syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SCCAL

Naples, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

InositolPhytoestrogens

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesEstrogens, Non-SteroidalEstrogensHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Mario Passaro, MD

    ASL NA3 Sud, Naples, Italy.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

September 30, 2022

Primary Completion

June 30, 2023

Study Completion

August 15, 2023

Last Updated

November 8, 2023

Record last verified: 2023-09

Locations

IT(1)