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

March 23, 2025 updated by: Giuseppe Derosa, Fondazione IRCCS Policlinico San Matteo di Pavia
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effect on cholesterol and glycemia
Time Frame: 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
LDL and HDL-cholesterol
Time Frame: 6 months
Effetcs of the two treatments on LDL-Cholesterol and HDL-Cholesterol
6 months
Glycemic status
Time Frame: 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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