Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women

Completed

• Conditions: Metabolic Syndrome; Menopause; Climacteric Syndrome
• Interventions: Dietary Supplement: inositol, phytoestrogens, cocoa polyphenols

• Registration Number: NCT06057896
• Lead Sponsor: Lo.Li.Pharma s.r.l

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-30
• Primary Completion: 2023-06-30
• Study Completion: 2023-08-15
• Status Verified: 2023-09
• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
inositol, phytoestrogens, cocoa polyphenols	inositol, phytoestrogens, cocoa polyphenols	-

Primary Outcome Measures

Name	Time	Method
Body mass index	[0, 6 months]	Change of body weight

Secondary Outcome Measures

Name	Time	Method
Climacteric	[0, 6 months]	Changes of number of flushes
Climateric	[0, 6 months]	Changes of intensity of flushes measured through questionnaire

Trial Locations

Locations (1)

SCCAL; 🇮🇹 Naples, Italy