Clinical trial NCT06901076: Effect of a Food Supplement Based on Nigella Sativa Seeds Oil and Vitamin E on Glyco-lipid Parameters in Dysglycemic and Dyslipidemic Perimenopausal Women
Official title: Effect of a Food Supplement Based on Nigella Sativa Seeds Oil and Vitamin E on Glyco-lipid Parameters in Dysglycemic and Dyslipidemic Perimenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perimenopausal Disorder
Impaired Glucose Tolerance
Impaired Fasting Glycemia
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized, placebo-controlled, double-blind, parallel-groups trial
Primary purpose: TREATMENT

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 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.

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 dyslipidemic will be evaluate. Blood sample analysis will be prescribed to be performed before the next visit for the evaluation of FPG, FPI, TC, HDL-C, Tg, ALT, AST, uric acid, creatinine, lipoprotein(a) \[Lp(a)\], high sensitive C-reactive protein (hs-CRP), 25-hydroxyvitamin D3 (25-OH D3), follicle stimulating hormone (FSH), estradiol, androstenedione, dehydroepiandrosterone sulphate (DHEAS), cortisol, thyroid stimulating hormone (TSH). Blood sample analysis will be performed in amenorrhea or within the first 3 days of the menstrual cycle. Adiponectin (ADN), resistin, oxidized LDL (oxLDL) and malondialdehyde (MDA) will be assessed by using enzyme-linked immunosorbent assay (ELISA) kits commercially available. At the baseline visit, a 12-lead ECG will be recorded to exclude ischemic disease and a computerized medical record will be compiled where the following data will be recorded: vital signs \[waist circumference, abdomen circumference, hip circumference, weight, height, body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR)\] the laboratory tests (FPG, FPI, TC, HDL-C, Tg, ALT, AST, uric acid, creatinine, Lp(a), hs-CRP, 25-OH D3, FSH, estradiol, androstenedione, DHEAS, cortisol, TSH) and the parameters detected with ELISA kits (ADN, resistin, oxLDL and MDA). There will be calculated LDL-C and homeostasis model assessment of insulin resistance (HOMA-IR). Perimenopausal symptoms were assessed using WHQ and estrogen-androgenic climacteric syndrome questionnaires. In addition anxiety and depression were evaluated in perimenopausal women with the HADS. The female sexual function index and the FSDS were used for the measurement of sexual function and distress. The perimenopausal women will be randomized in one of the 2 groups to receive the food supplement or placebo and a sufficient amount of study product for 6 months will be delivered. All subjects will receive dietary recommendations. After 3 months of treatment vital signs will be recorded. The Investigator will verify the product tolerability. Any adverse events eventually occurred will be collected. Perimenopausal symptoms were assessed using WHQ and estrogen-androgenic climacteric syndrome questionnaires. In additionanxiety and depression were evaluated in perimenopausal women with the HADS. The female sexual function index and the FSDS were used for the measurement of sexual function and distress. Blood sample analysis will be prescribed to be performed before the next visit for the evaluation of FPG, FPI, TC, HDL-C, Tg, ALT, AST, uric acid, creatinine, Lp(a), hs-CRP, 25-OH D3, FSH, estradiol, androstenedione, DHEAS, cortisol, TSH. After 6 months of treatment, following blood samples collection, the perimenopausal women will be undergone to an OGTT to reevaluate the dysglycemia status at the end of the study; laboratory tests and the parameters detected with ELISA kits will be recorded. There will be calculated LDL-C and HOMA-IR. The Investigator will verify the product tolerability. Any adverse events eventually occurred will be collected. Perimenopausal symptoms were assessed using WHQ and estrogenandrogenic climacteric syndrome questionnaires. In addition anxiety and depression were evaluated in perimenopausal women with the HADS. The female sexual function index and the FSDS were used for the measurement of sexual function and distress.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* neoplastic diseases
* liver diseases
* renal insufficiency
* diabetes mellitus

Primary outcomes:
measure: Effect on cholesterol and glycemia
timeFrame: 6 months
Secondary outcomes:
measure: LDL and HDL-cholesterol
timeFrame: 6 months
measure: Glycemic status
timeFrame: 6 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, SC Medicina Generale 1
Study officials:
References: