Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women

• Sponsor: Lo.Li.Pharma s.r.l (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06057896
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Actual Duration (Months): 10.5
• Patients Per Site Per Month: 19.1

Study Details

Study Description

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	Phase
Menopause; Climacteric Syndrome; Metabolic Syndrome	Dietary Supplement: inositol, phytoestrogens, cocoa polyphenols

Study Design

• 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: Sep 30, 2022
• Actual Primary Completion Date: Jun 30, 2023
• Actual Study Completion Date: Aug 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
inositol, phytoestrogens, cocoa polyphenols	Dietary Supplement: inositol, phytoestrogens, cocoa polyphenols; myo-inositol, soy isoflavones and cocoa polyphenols

Outcome Measures

Primary Outcome Measures

1. Body mass index [[0, 6 months]]

   Change of body weight

Secondary Outcome Measures

1. Climacteric [[0, 6 months]]

   Changes of number of flushes

2. Climateric [[0, 6 months]]

   Changes of intensity of flushes measured through questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	SCCAL	Naples		Italy

Sponsors and Collaborators

• Lo.Li.Pharma s.r.l

Investigators

• Principal Investigator: Mario Passaro, MD, ASL NA3 Sud, Naples, Italy.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lo.Li.Pharma s.r.l
• ClinicalTrials.gov Identifier: NCT06057896
• Other Study ID Numbers: Ins-SM-23
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 29, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome; Inositol; Phytoestrogens

Study Results

No Results Posted as of Sep 29, 2023