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

Liaquat University of Medical & Health Sciences

Status: Not yet enrolling

Conditions: Elevated Blood Pressure; Metabolic Syndrome

Treatments: Behavioral: Mediterranean Diet; Dietary Supplement: Nigella sativa extract (Nisatol®)

Study type: Interventional

Funder types: Other

Identifiers

NCT07013058

134_21May2025_NISATOL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Nisatol® Supplement Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nigella sativa extract (Nisatol®)

Mediterranean Diet Group

Active Comparator group

Description:

Participants in this arm will follow a Mediterranean diet for 4 months. No Nigella sativa supplement will be administered.

Treatment:

Behavioral: Mediterranean Diet