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

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.

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.

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