Effects of Combined Natural Molecules on Metabolic Syndro... | NCT06057896

Studies
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women

NCT06057896

Sponsor

Lo.Li.Pharma s.r.l

Status

Completed

Last Update Posted

Nov 8, 2023Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Menopause
Climacteric Syndrome
Metabolic Syndrome

Interventions

inositol, phytoestrogens, cocoa polyphenols

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2022Actual

Primary Completion Date

Jun 30, 2023Actual

Completion Date

Aug 15, 2023Actual

First Submitted Date

Sep 21, 2023

First Submission Date that Met QC Criteria

Sep 21, 2023

First Posted Date

Sep 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2023

Last Update Posted Date

Nov 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
inositol, phytoestrogens, cocoa polyphenols			Dietary Supplement: inositol, phytoestrogens, cocoa polyphenols

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inositol, phytoestrogens, cocoa polyphenols	Dietary Supplement	myo-inositol, soy isoflavones and cocoa polyphenols	inositol, phytoestrogens, cocoa polyphenols

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

menopause
diagnosis of metabolic syndrome

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mario Passaro, MD	ASL NA3 Sud, Naples, Italy.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SCCAL		Naples			Italy

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007294	Inositol
D048789	Phytoestrogens

Ancestor Terms

ID	Term
D013402	Sugar Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided