Metabolic SyndromeNCT07013058

Evaluation of a Nigella Sativa Extract (10% Thymoquinone, Nisatol®) in Perimenopausal Women With Metabolic Syndrome

A study testing Nigella sativa extract (Nisatol®) and Mediterranean Diet in people with Metabolic Syndrome and Elevated Blood Pressure, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Metabolic Syndrome, Elevated Blood Pressure
What is being tested?: Nigella sativa extract (Nisatol®) and Mediterranean Diet
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteItaly
Study dates: 15 Jun 2025to 19 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

Perimenopausal women aged 40-60 years
Presence of climacteric (menopausal) symptoms
Diagnosis of metabolic syndrome, defined as alteration of at least 3 of the following:
Systolic blood pressure ≥130 mmHg and/or diastolic ≥85 mmHg
HDL cholesterol <50 mg/dL
Triglycerides ≥150 mg/dL
Fasting blood glucose ≥100 mg/dL
Uricemia >7 mg/dL

Who cannot join

Use of hormone replacement therapy (HRT)
Presence of neoplastic diseases
Presence of liver disease, kidney failure, or diabetes mellitus
Drug or alcohol abuse
Known hypersensitivity to Nigella sativa or any formulation component

Trial locations and contacts

1 site in 1 country.

Italy1 site

ASL Frosinone, Dipartimento di Prevenzione,
Frosinone, 03100

Other trials in Italy

About this study

Official title: Evaluation of the Efficacy of a Nigella Sativa Extract Standardized to 10% Thymoquinone (Nisatol®) in Improving Metabolic and Blood Pressure Parameters and Quality of Life in Perimenopausal Women With Metabolic Syndrome: A Prospective, Multicenter, Randomized Controlled Clinical Trial

A prospective, multicenter, randomized controlled study evaluating the efficacy and safety of a Nigella sativa extract standardized to 10% thymoquinone (Nisatol®) in perimenopausal women with metabolic syndrome. The study will assess changes in metabolic and blood pressure parameters, as well as improvements in menopausal symptoms and quality of life.

Read the detailed description

This prospective, multicenter, randomized controlled clinical trial aims to evaluate the efficacy and safety of a food supplement containing Nigella sativa oil standardized to 10% thymoquinone (Nisatol®) in perimenopausal women diagnosed with metabolic syndrome and experiencing climacteric symptoms.

Fifty participants will be randomly assigned to either the intervention group (receiving 2 softgel capsules of Nisatol® daily for 4 months) or a control group following a Mediterranean diet. The primary endpoint is the change from baseline in metabolic and blood pressure parameters, including fasting glucose, lipid profile, cortisolemia, uricemia, and systolic/diastolic blood pressure. The study will also assess quality of life using the Greene Climacteric Scale and monitor treatment safety and tolerability.

The study addresses the need for non-hormonal, evidence-based interventions for managing metabolic and menopausal symptoms in midlife women.

Conditions: Metabolic Syndrome, Elevated Blood Pressure
Being tested: Nigella sativa extract (Nisatol®), Mediterranean Diet
Medical subject headings: Metabolic Syndrome, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nigella sativa extract (Nisatol®)Dietary supplement
Participants will take 2 softgel capsules daily of Nigella sativa oil standardized to 10% thymoquinone (Nisatol®), one capsule with lunch and one with dinner, for 4 months.
Mediterranean DietBehavioural
Participants will follow a Mediterranean diet for 4 months under dietary guidance, without receiving any Nigella sativa supplementation.

Study groups in NCT07013058
Study group	Role	What they receive
Nisatol® Supplement Group	Experimental	Participants in this arm will receive 2 softgel capsules per day of Nigella sativa oil standardized to 10% thymoquinone (Nisatol®), one capsule with lunch and one with dinner, for a total duration of 4 months. Receives: Dietary Supplement: Nigella sativa extract (Nisatol®)
Mediterranean Diet Group	Active comparator	Participants in this arm will follow a Mediterranean diet for 4 months. No Nigella sativa supplement will be administered. Receives: Behavioral: Mediterranean Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Fasting Blood Glucose
Evaluation of the change in fasting blood glucose from baseline to 4 months.
Measured: Baseline to 4 months
Change in Total Cholesterol levels, (mg/dL)
Evaluation of total cholesterol from baseline to 4 months.
Measured: Baseline to 4 months
Change in low-density lipoprotein cholesterol levels, (mg/dL)
Evaluation of low-density lipoprotein cholesterol from baseline to 4 months.
Measured: Baseline to 4 months
Change in high-density lipoprotein cholesterol levels, (mg/dL)
Evaluation of high-density lipoprotein cholesterol from baseline to 4 months.
Measured: Baseline to 4 months
Change in Triglycerides levels, (mg/dL)
Evaluation of triglyceride levels from baseline to 4 months.
Measured: Baseline to 4 months
Change in Blood Pressure
Evaluation of the change in systolic and diastolic blood pressure from baseline to 4 months.
Measured: Baseline to 4 months
Change in Serum Cortisol levels, (μg/dL)
Evaluation of Cortisol levels from baseline to 4 months.
Measured: Baseline to 4 months
Change in Serum Uric Acid levels, (mg/dL)
Evaluation of Uric acid levels from baseline to 4 months.
Measured: Baseline to 4 months
Change in serum Alanine Aminotransferase Enzyme levels, (U/L)
Evaluation of Alanine Aminotransferase Enzyme levels from baseline to 4 months.
Measured: Baseline to 4 months
Change in serum Aspartate Aminotransferase Enzyme levels, (U/L)
Evaluation of Aspartate Aminotransferase Enzyme levels from baseline to 4 months.
Measured: Baseline to 4 months
Change in serum Change in Serum Creatinine levels, (mg/dL or µmol/L)
Evaluation of serum creatinine from baseline to 4 months.
Measured: Baseline to 4 months
Change in serum Creatine Phosphokinase Enzymes levels, (U/L)
Evaluation of Creatine Phosphokinase Enzymes levels from baseline to 4 months.
Measured: Baseline to 4 months
Change in Climacteric Symptoms
Evaluation using the Greene Climacteric Scale, a 21-item self-reported questionnaire where each item is rated from 0 (not at all) to 3 (extremely), with a total score range from 0 to 63. Higher scores indicate more severe symptoms. Changes will be measured from baseline to 4 months.
Measured: Baseline to 4 months

Secondary outcomes (1)

Safety and Tolerability
Evaluation of adverse events, tolerability score (0-10), and adherence rate (%) over the 4-month treatment period.
Measured: Throughout study duration (4 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 202519 Dec 2025

First posted10 Jun 2025
Study start15 Jun 2025
Primary completion30 Nov 2025
Study completion19 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized in a 1:1 ratio to receive either Nisatol® (Nigella sativa extract) or follow a Mediterranean diet for 4 months.
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07013058
Sponsor's protocol ID: 134_21May2025_NISATOL
Status last verified: Dec 2025
First submitted: 29 May 2025
Last updated: 30 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Efficacy of a Nigella Sativa Extract Standardized to 10% Thymoquinone (Nisatol®) in Improving Metabolic and Blood Pressure Parameters and Quality of Life in Perimenopausal Women With Metabolic Syndrome: A Prospective, Multicenter, Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT07013058
Acronym / sponsor ID: 134_21May2025_NISATOL
Conditions: Metabolic Syndrome, Elevated Blood Pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Liaquat University of Medical & Health SciencesUniversity, hospital or other
Collaborators: University of Urbino "Carlo Bo"
Study start: 15 Jun 2025 (actual)
Primary completion: 30 Nov 2025 (actual)
Study completion: 19 Dec 2025 (actual)
First posted: 10 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study addresses the need for non-hormonal, evidence-based interventions for managing metabolic and menopausal symptoms in midlife women.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be randomized in a 1:1 ratio to receive either Nisatol® (Nigella sativa extract) or follow a Mediterranean diet for 4 months.

Arm	Type	Receives
Nisatol® Supplement Group	Experimental	Dietary Supplement: Nigella sativa extract (Nisatol®)Participants in this arm will receive 2 softgel capsules per day of Nigella sativa oil standardized to 10% thymoquinone (Nisatol®), one capsule with lunch and one with dinner, for a total duration of 4 months.
Mediterranean Diet Group	Active comparator	Behavioral: Mediterranean DietParticipants in this arm will follow a Mediterranean diet for 4 months. No Nigella sativa supplement will be administered.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Perimenopausal women aged 40-60 years
Presence of climacteric (menopausal) symptoms
Diagnosis of metabolic syndrome, defined as alteration of at least 3 of the following:

Key exclusion criteria (5 listed)

Use of hormone replacement therapy (HRT)
Presence of neoplastic diseases
Presence of liver disease, kidney failure, or diabetes mellitus
Drug or alcohol abuse
Known hypersensitivity to Nigella sativa or any formulation component

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nigella sativa extract (Nisatol®)Participants will take 2 softgel capsules daily of Nigella sativa oil standardized to 10% thymoquinone (Nisatol®), one capsule with lunch and one with dinner, for 4 months.	Dietary supplement	Nisatol® Supplement Group
Mediterranean DietParticipants will follow a Mediterranean diet for 4 months under dietary guidance, without receiving any Nigella sativa supplementation.	Behavioural	Mediterranean Diet Group

Primary outcome

Change in Fasting Blood Glucose
Time frame: Baseline to 4 months
Evaluation of the change in fasting blood glucose from baseline to 4 months.
Change in Total Cholesterol levels, (mg/dL)
Time frame: Baseline to 4 months
Evaluation of total cholesterol from baseline to 4 months.
Change in low-density lipoprotein cholesterol levels, (mg/dL)
Time frame: Baseline to 4 months
Evaluation of low-density lipoprotein cholesterol from baseline to 4 months.
Change in high-density lipoprotein cholesterol levels, (mg/dL)
Time frame: Baseline to 4 months
Evaluation of high-density lipoprotein cholesterol from baseline to 4 months.
Change in Triglycerides levels, (mg/dL)
Time frame: Baseline to 4 months
Evaluation of triglyceride levels from baseline to 4 months.
Change in Blood Pressure
Time frame: Baseline to 4 months
Evaluation of the change in systolic and diastolic blood pressure from baseline to 4 months.
Change in Serum Cortisol levels, (μg/dL)
Time frame: Baseline to 4 months
Evaluation of Cortisol levels from baseline to 4 months.
Change in Serum Uric Acid levels, (mg/dL)
Time frame: Baseline to 4 months
Evaluation of Uric acid levels from baseline to 4 months.
Change in serum Alanine Aminotransferase Enzyme levels, (U/L)
Time frame: Baseline to 4 months
Evaluation of Alanine Aminotransferase Enzyme levels from baseline to 4 months.
Change in serum Aspartate Aminotransferase Enzyme levels, (U/L)
Time frame: Baseline to 4 months
Evaluation of Aspartate Aminotransferase Enzyme levels from baseline to 4 months.
Change in serum Change in Serum Creatinine levels, (mg/dL or µmol/L)
Time frame: Baseline to 4 months
Evaluation of serum creatinine from baseline to 4 months.
Change in serum Creatine Phosphokinase Enzymes levels, (U/L)
Time frame: Baseline to 4 months
Evaluation of Creatine Phosphokinase Enzymes levels from baseline to 4 months.
Change in Climacteric Symptoms
Time frame: Baseline to 4 months
Evaluation using the Greene Climacteric Scale, a 21-item self-reported questionnaire where each item is rated from 0 (not at all) to 3 (extremely), with a total score range from 0 to 63. Higher scores indicate more severe symptoms. Changes will be measured from baseline to 4 months.

1 secondary outcome

Safety and Tolerability
Time frame: Throughout study duration (4 months)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Individual participant dataSharing planned: No

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fasting Blood Glucose (time frame: Baseline to 4 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07013058.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.