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| Name | Class |
|---|---|
| University of Urbino "Carlo Bo" | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Mediterranean Diet Group | Active Comparator | Participants in this arm will follow a Mediterranean diet for 4 months. No Nigella sativa supplement will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASL Frosinone, Dipartimento di Prevenzione, | Frosinone | 03100 | Italy |
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Participants will be randomized in a 1:1 ratio to receive either Nisatol® (Nigella sativa extract) or follow a Mediterranean diet for 4 months.
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| Mediterranean Diet | Behavioral | Participants will follow a Mediterranean diet for 4 months under dietary guidance, without receiving any Nigella sativa supplementation. |
|
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 |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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