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.
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
History of cardiovascular disease
Diabetes mellitus
Severe chronic diseases
Use of medications affecting blood pressure or heart rate
Parallel
Nigella sativa (Nisatol®)
Dietary supplementStandardized Nigella sativa extract (Nisatol®) administered orally 2 capsules per day (one capsule in the morning and one in the evening) for 12 weeks.
Placebo
Other interventionPlacebo capsules identical in appearance to the Nigella sativa (Nisatol®) 2 capsules per day administered for 12 weeks.
Change in systolic blood pressure (mmHg)
Assessment of the change in systolic blood pressure measured in mmHg between baseline and Week 12 in women with high-normal systolic blood pressure values (≥130 mmHg) and/or a nocturnal non-dipper hypertension phenotype.
Change in diastolic blood pressure (mmHg)
Assessment of the change in diastolic blood pressure measured in mmHg between baseline and Week 12 in women with high-normal diastolic blood pressure values (≥85 mmHg) and/or a nocturnal non-dipper hypertension phenotype.
Change in resting heart rate (beats per minute)
Assessment of the change in resting heart rate measured in beats per minute (bpm) between baseline and Week 12 in women presenting climacteric symptoms and/or resting heart rate above 80 bpm.
Change in total cholesterol (mg/dL)
Assessment of the change in total cholesterol concentration measured in mg/dL between baseline and Week 12
Change in LDL cholesterol (mg/dL)
Assessment of the change in low-density lipoprotein (LDL) cholesterol concentration measured in mg/dL between baseline and Week 12.
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Liaquat University of Medical & Health Sciences
Lead sponsor
University of Rome Tor Vergata
Collaborator
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