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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Elevated Blood Pressure
• Intervention / Treatment: Dietary supplement: Nigella sativa extract (Nisatol®); Behavioral: Mediterranean Diet

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Frosinone, Italy, 03100
    • ASL Frosinone, Dipartimento di Prevenzione,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nisatol® Supplement Group; 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.	Dietary supplement: 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.
Active Comparator: Mediterranean Diet Group; Participants in this arm will follow a Mediterranean diet for 4 months. No Nigella sativa supplement will be administered.	Behavioral: Mediterranean Diet; Participants will follow a Mediterranean diet for 4 months under dietary guidance, without receiving any Nigella sativa supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Blood Glucose	Evaluation of the change in fasting blood glucose from baseline to 4 months.	Baseline to 4 months
Change in Total Cholesterol levels, (mg/dL)	Evaluation of total cholesterol from baseline to 4 months.	Baseline to 4 months
Change in low-density lipoprotein cholesterol levels, (mg/dL)	Evaluation of low-density lipoprotein cholesterol from baseline to 4 months.	Baseline to 4 months
Change in high-density lipoprotein cholesterol levels, (mg/dL)	Evaluation of high-density lipoprotein cholesterol from baseline to 4 months.	Baseline to 4 months
Change in Triglycerides levels, (mg/dL)	Evaluation of triglyceride levels from baseline to 4 months.	Baseline to 4 months
Change in Blood Pressure	Evaluation of the change in systolic and diastolic blood pressure from baseline to 4 months.	Baseline to 4 months
Change in Serum Cortisol levels, (μg/dL)	Evaluation of Cortisol levels from baseline to 4 months.	Baseline to 4 months
Change in Serum Uric Acid levels, (mg/dL)	Evaluation of Uric acid levels from baseline to 4 months.	Baseline to 4 months
Change in serum Alanine Aminotransferase Enzyme levels, (U/L)	Evaluation of Alanine Aminotransferase Enzyme levels from baseline to 4 months.	Baseline to 4 months
Change in serum Aspartate Aminotransferase Enzyme levels, (U/L)	Evaluation of Aspartate Aminotransferase Enzyme levels from baseline to 4 months.	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.	Baseline to 4 months
Change in serum Creatine Phosphokinase Enzymes levels, (U/L)	Evaluation of Creatine Phosphokinase Enzymes levels from baseline to 4 months.	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.	Baseline to 4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: University of Urbino "Carlo Bo"

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): December 19, 2025

Study Registration Dates

• First Submitted: May 29, 2025
• First Submitted That Met QC Criteria: June 5, 2025
• First Posted (Actual): June 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Hypertension; Metabolic Syndrome; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Diet, Mediterranean
• Other Study ID Numbers: 134_21May2025_NISATOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No