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
Liaquat University of Medical & Health Sciences
Lead sponsor
University of Rome Tor Vergata
Collaborator