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

NCT07013058 | Completed DMC

• 1 other identifier: 134_21May2025_NISATOL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Elevated Blood Pressure

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (1)

• Safety and Tolerability

  Throughout study duration (4 months)

Study Arms (2)

Nisatol® Supplement Group

EXPERIMENTAL

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®)

Mediterranean Diet Group

ACTIVE COMPARATOR

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

Behavioral: Mediterranean Diet

Interventions

Mediterranean Diet BEHAVIORAL

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

Mediterranean Diet Group

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.

Nisatol® Supplement Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• University of Urbino "Carlo Bo": collaborator

Study Sites (1)

ASL Frosinone, Dipartimento di Prevenzione,

Frosinone, 03100, Italy

Location

MeSH Terms

Conditions

Metabolic Syndrome; Hypertension

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental medicine

Model Details: Participants will be randomized in a 1:1 ratio to receive either Nisatol® (Nigella sativa extract) or follow a Mediterranean diet for 4 months.

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 10, 2025
• Study Start: June 15, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 19, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)