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NCT Number: NCT07013058

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

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.

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Key information

Conditions

Metabolic Syndrome Cardiovascular Diseases Elevated Blood Pressure Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ASL Frosinone, Dipartimento di Prevenzione,

Frosinone, 03100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Diet

Behavioral

Participants will follow a Mediterranean diet for 4 months under dietary guidance, without receiving any Nigella sativa supplementation.

Primary outcomes

  1. Change in Fasting Blood Glucose

    Time frame: Baseline to 4 months

    Evaluation of the change in fasting blood glucose from baseline to 4 months.

  2. Change in Total Cholesterol levels, (mg/dL)

    Time frame: Baseline to 4 months

    Evaluation of total cholesterol from baseline to 4 months.

  3. 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.

  4. 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.

  5. Change in Triglycerides levels, (mg/dL)

    Time frame: Baseline to 4 months

    Evaluation of triglyceride levels from baseline to 4 months.

  6. 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.

  7. Change in Serum Cortisol levels, (μg/dL)

    Time frame: Baseline to 4 months

    Evaluation of Cortisol levels from baseline to 4 months.

  8. Change in Serum Uric Acid levels, (mg/dL)

    Time frame: Baseline to 4 months

    Evaluation of Uric acid levels from baseline to 4 months.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Secondary outcomes

  1. Safety and Tolerability

    Time frame: Throughout study duration (4 months)

    Evaluation of adverse events, tolerability score (0-10), and adherence rate (%) over the 4-month treatment period.

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • University of Urbino "Carlo Bo"

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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