Effect of a Food Supplement Based on Nigella Sativa Seeds Oil and Vitamin E on Glyco-lipid Parameters in Dysglycemic and Dyslipidemic Perimenopausal Women
Effect of a Food Supplement Based on Nigella Sativa Seeds Oil and Vitamin E on Glyco-lipid Parameters in Dysglycemic and Dyslipidemic Perimenopausal Women
NCT ID: NCT06901076 Phase: NA Status: COMPLETED Enrollment: 120 Completion: 2025-02-11
Conditions
Perimenopausal Disorder, Impaired Glucose Tolerance, Impaired Fasting Glycemia
Interventions
Nisatol, Placebo
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 treatment inlcude Nisatol® (developed by PharmExtracta) containing Nigella sativa seeds oil and Vitamin E, 1 capsule soft gel after breakfast and 1 capsule soft gel after dinner for 6 months; Control Intervention is Placebo.
Primary Outcome
Effect on cholesterol and glycemia