Effect of a Food Supplement Based on Nigella Sativa Seeds Oil and Vitamin E on Glyco-lipid Parameters in Dysglycemic and Dyslipidemic Perimenopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Impaired Glucose Tolerance; Perimenopausal Disorder; Impaired Fasting Glycemia
• Intervention / Treatment: Other: Placebo; Dietary supplement: Nisatol

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo, SC Medicina Generale 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Experimental: Nisatol; 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	Dietary supplement: Nisatol; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on cholesterol and glycemia	The primary outcome is the comparison of two arms (Nisatol® supplement vs Placebo) for the effects on fasting plasma glucose and total cholesterol	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL and HDL-cholesterol	Effetcs of the two treatments on LDL-Cholesterol and HDL-Cholesterol	6 months
Glycemic status	Proportion of perimenopausal women passing from impaired fasting glucose condition to euglycemia; from impaired glucose tolerance condition to euglycemia; from impaired fasting glucose condition to diabetes; from impaired glucose tolerance condition to diabetes	6 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Actual): February 11, 2025
• Study Completion (Actual): February 11, 2025

Study Registration Dates

• First Submitted: March 23, 2025
• First Submitted That Met QC Criteria: March 23, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: NST 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be presented and discussed in an original article

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No