Efficacy of Nigella Sativa (Nisatol®) in Women With Borderline Blood Pressure Values or a Non-Dipper Blood Pressure Phenotype

Liaquat University of Medical & Health Sciences

Status: Not yet enrolling

Conditions: Hypertension; Prehypertension

Treatments: Other: Placebo; Dietary Supplement: Nigella sativa (Nisatol®)

Study type: Interventional

Funder types: Other

Identifiers

NCT07494279

97-2023/20.04.2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups, including a placebo group

Nisatol®

Experimental group

Description:

Participants randomized to this arm will receive Nigella sativa extract (Nisatol®) capsules (2 capsules per day, one capsule in the morning and one in the evening) for 12 weeks.

Treatment:

Dietary Supplement: Nigella sativa (Nisatol®)

Placebo

Placebo Comparator group

Description:

Participants randomized to this arm will receive placebo capsules identical in appearance to the Nisatol® capsules (2 capsules per day, one capsule in the morning and one in the evening) for 12 weeks.

Treatment:

Other: Placebo