Clinical trial NCT07013058: Evaluation of a Nigella Sativa Extract (10% Thymoquinone, Nisatol®) in Perimenopausal Women With Metabolic Syndrome
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Elevated Blood Pressure
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Urbino "Carlo Bo"
First posted: 2025-06-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Fasting Blood Glucose
timeFrame: Baseline to 4 months
measure: Change in Total Cholesterol levels, (mg/dL)
timeFrame: Baseline to 4 months
measure: Change in low-density lipoprotein cholesterol levels, (mg/dL)
timeFrame: Baseline to 4 months
measure: Change in high-density lipoprotein cholesterol levels, (mg/dL)
timeFrame: Baseline to 4 months
measure: Change in Triglycerides levels, (mg/dL)
timeFrame: Baseline to 4 months
measure: Change in Blood Pressure
timeFrame: Baseline to 4 months
measure: Change in Serum Cortisol levels, (μg/dL)
timeFrame: Baseline to 4 months
measure: Change in Serum Uric Acid levels, (mg/dL)
timeFrame: Baseline to 4 months
measure: Change in serum Alanine Aminotransferase Enzyme levels, (U/L)
timeFrame: Baseline to 4 months
measure: Change in serum Aspartate Aminotransferase Enzyme levels, (U/L)
timeFrame: Baseline to 4 months
measure: Change in serum Change in Serum Creatinine levels, (mg/dL or µmol/L)
timeFrame: Baseline to 4 months
measure: Change in serum Creatine Phosphokinase Enzymes levels, (U/L)
timeFrame: Baseline to 4 months
measure: Change in Climacteric Symptoms
timeFrame: Baseline to 4 months
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: Throughout study duration (4 months)
Other outcomes:
Locations:
city: Frosinone
country: Italy
facility: ASL Frosinone, Dipartimento di Prevenzione,
Study officials:
References: