Efficacy of Nigella Sativa (Nisatol®) in Women With Borderline Blood Pressure Values or a Non-Dipper Blood Pressure Phenotype
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nigella sativa (Nisatol®), Placebo.
- Who it may be relevant to
- Registry conditions: Prehypertension, Hypertension. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Nigella Sativa (Nisatol®) Supplementation in Women With Borderline Blood Pressure Values or a Non-Dipper Blood Pressure Phenotype: A Randomized Placebo-Controlled Study With Dietary Intervention Phase
Overview
This randomized placebo-controlled study evaluates the efficacy of Nigella sativa (Nisatol®) supplementation in women with borderline blood pressure values or a non-dipper blood pressure phenotype. The study aims to assess the effects of supplementation on blood pressure and resting heart rate in women presenting high-normal blood pressure values (≥130/85 mmHg) and/or a nocturnal non-dipper blood pressure pattern. Participants will be randomly assigned to receive either Nigella sativa (Nisatol®) or placebo for 12 weeks. After the treatment phase, a washout period will be followed by a dietary intervention phase combined with alternate treatment according to the study design. Cardiological and nutritional assessments will be performed at predefined time points.
Detailed description
Hypertension represents one of the main risk factors for cardiovascular diseases, which remain the leading cause of mortality worldwide. In women, cardiovascular risk is often underestimated, resulting in lower adherence to preventive screening and frequent presentation at more advanced stages of cardiovascular disease.
Many women present borderline blood pressure values or altered circadian blood pressure patterns, such as the non-dipper phenotype. These conditions may be associated with increased cardiovascular risk and may significantly affect quality of life, particularly in women experiencing climacteric symptoms.
Nigella sativa (black cumin seed) has attracted increasing interest as a nutraceutical strategy for improving cardiovascular and metabolic health. Preliminary evidence suggests that supplementation with Nigella sativa may have beneficial effects on blood pressure, lipid profile, and heart rate.
This randomized controlled trial will evaluate the efficacy of Nigella sativa (Nisatol®) supplementation compared with placebo in women with borderline blood pressure values and/or a non-dipper blood pressure phenotype. Participants will be randomly assigned to either the intervention group receiving Nisatol® or a control group receiving placebo using formulations that are visually indistinguishable.
The initial treatment phase will last 12 weeks. After this phase, treatment will be discontinued and participants will undergo a washout period. Following the washout period, participants will begin a dietary intervention based on a standardized Mediterranean diet combined with the alternate treatment according to the study design.
Participants will be evaluated at predefined time points (baseline, 4 weeks, 12 weeks, and final evaluation) to monitor blood pressure, resting heart rate, adherence to treatment, and potential adverse events. Additional assessments will include lipid profile, fasting blood glucose, body composition parameters, gut microbiota analysis, urinary metabolite analysis, and quality-of-life evaluation using validated questionnaires.
The results of this study are expected to provide additional evidence regarding the potential role of Nigella sativa supplementation as a nutraceutical strategy for improving cardiovascular parameters and metabolic health in women with borderline blood pressure values.
Interventions
- Dietary supplement Nigella sativa (Nisatol®)
Standardized Nigella sativa extract (Nisatol®) administered orally 2 capsules per day (one capsule in the morning and one in the evening) for 12 weeks. - Other Placebo
Placebo capsules identical in appearance to the Nigella sativa (Nisatol®) 2 capsules per day administered for 12 weeks.
Primary outcome measures
- Change in systolic blood pressure (mmHg) [Time frame: Baseline to Week 12]
Secondary outcome measures (12)
- Change in diastolic blood pressure (mmHg) [Time frame: Baseline to Week 12]
- Change in resting heart rate (beats per minute) [Time frame: Baseline to Week 12]
- Change in total cholesterol (mg/dL) [Time frame: Baseline to Week 12]
- Change in LDL cholesterol (mg/dL) [Time frame: Baseline to Week 12]
- Change in HDL cholesterol (mg/dL) [Time frame: Baseline to Week 12]
- Change in triglycerides (mg/dL) [Time frame: Baseline to Week 12]
- Change in fasting blood glucose (mg/dL) [Time frame: Baseline to Week 12]
- Change in urinary metabolite concentrations [Time frame: Baseline to Week 12]
- Change in gut microbiota composition assessed by 16S rRNA sequencing [Time frame: Baseline to Week 12]
- Change in quality of life assessed by validated questionnaire (SF-36) [Time frame: Baseline to Week 12]
- Change in body weight (kg) [Time frame: Baseline to Week 12]
- Change in body fat percentage (%) [Time frame: Baseline to Week 12]
Eligibility criteria
Inclusion criteria
- Female participants
- High-normal blood pressure values (≥130/85 mmHg) or mild hypertension (140/90 mmHg) with low cardiovascular risk and no current indication for pharmacological therapy
- Presence of a non-dipper blood pressure phenotype on 24-hour ambulatory blood pressure monitoring
- Absence of antihypertensive pharmacological treatment Exclusion Criteria
- History of cardiovascular disease
- Diabetes mellitus
- Severe chronic diseases
- Use of medications affecting blood pressure or heart rate
- Known allergy to Nigella sativa or fennel
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- University of Rome Tor Vergata — Roma
Identifiers
NCT: NCT07494279 · 97-2023/20.04.2023