Status:
COMPLETED
Effect of a Food Supplement Based on Nigella Sativa Seeds Oil and Vitamin E on Glyco-lipid Parameters in Dysglycemic and Dyslipidemic Perimenopausal Women
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Perimenopausal Disorder
Impaired Glucose Tolerance
Eligibility:
FEMALE
Phase:
NA
Brief Summary
A total of 120 subjects in one center will be enrolled and will be divided into two treatment groups of 60 subjects each with 1:1 allocation ratio. Permuted block randomization will be used. Active tr...
Detailed Description
In the screening visit subject's demographic data, medical history, comorbidities and concomitant medication will be collected. Patients who are dysglycemic following OGTT and who are also dyslipidemi...
Eligibility Criteria
Inclusion
- perimenopausal women (irregular cycles up to intervals of more than 60 days)
- FPG values between 100 and 125 mg/dl and confirmation with oral glucose tolerance test (OGTT)
- TC values ≥ 200 mg/dl
Exclusion
- neoplastic diseases
- liver diseases
- renal insufficiency
- diabetes mellitus
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06901076
Start Date
March 12 2024
End Date
February 11 2025
Last Update
March 28 2025
Active Locations (1)
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1
Fondazione IRCCS Policlinico San Matteo, SC Medicina Generale 1
Pavia, Pavia, Italy, 27100