Elevated Blood Pressure, Metabolic Syndrome
Conditions
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.
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.
Interventions
BEHAVIORALMediterranean Diet
Participants will follow a Mediterranean diet for 4 months under dietary guidance, without receiving any Nigella sativa supplementation.
DIETARY_SUPPLEMENTNigella 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.
Sponsors
University of Urbino Carlo Bo
Liaquat University of Medical & Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either Nisatol® (Nigella sativa extract) or follow a Mediterranean diet for 4 months.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Climacteric Symptoms | Baseline to 4 months | 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. |
| Change in Serum Cortisol levels, (μg/dL) | Baseline to 4 months | Evaluation of Cortisol levels from baseline to 4 months. |
| Change in Serum Uric Acid levels, (mg/dL) | Baseline to 4 months | Evaluation of Uric acid levels from baseline to 4 months. |
| Change in Fasting Blood Glucose | Baseline to 4 months | Evaluation of the change in fasting blood glucose from baseline to 4 months. |
| Change in Total Cholesterol levels, (mg/dL) | Baseline to 4 months | Evaluation of total cholesterol from baseline to 4 months. |
| Change in low-density lipoprotein cholesterol levels, (mg/dL) | Baseline to 4 months | Evaluation of low-density lipoprotein cholesterol from baseline to 4 months. |
| Change in high-density lipoprotein cholesterol levels, (mg/dL) | Baseline to 4 months | Evaluation of high-density lipoprotein cholesterol from baseline to 4 months. |
| Change in Triglycerides levels, (mg/dL) | Baseline to 4 months | Evaluation of triglyceride levels from baseline to 4 months. |
| Change in Blood Pressure | Baseline to 4 months | Evaluation of the change in systolic and diastolic blood pressure from baseline to 4 months. |
| Change in serum Alanine Aminotransferase Enzyme levels, (U/L) | Baseline to 4 months | Evaluation of Alanine Aminotransferase Enzyme levels from baseline to 4 months. |
| Change in serum Aspartate Aminotransferase Enzyme levels, (U/L) | Baseline to 4 months | Evaluation of Aspartate Aminotransferase Enzyme levels from baseline to 4 months. |
| Change in serum Change in Serum Creatinine levels, (mg/dL or µmol/L) | Baseline to 4 months | Evaluation of serum creatinine from baseline to 4 months. |
| Change in serum Creatine Phosphokinase Enzymes levels, (U/L) | Baseline to 4 months | Evaluation of Creatine Phosphokinase Enzymes levels from baseline to 4 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Throughout study duration (4 months) | Evaluation of adverse events, tolerability score (0-10), and adherence rate (%) over the 4-month treatment period. |
Countries
Italy
Outcome results
None listed