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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Change in systolic blood pressure (mmHg)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study is double-blind. Participants, care providers, investigators, and outcome assessors will be unaware of the treatment allocation. Nisatol® capsules and placebo capsules will be identical in appearance, packaging, and labeling to maintain blinding.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in systolic blood pressure (mmHg)
时间窗: Baseline to Week 12
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.
次要结局
- Change in diastolic blood pressure (mmHg)(Baseline to Week 12)
- Change in resting heart rate (beats per minute)(Baseline to Week 12)
- Change in total cholesterol (mg/dL)(Baseline to Week 12)
- Change in LDL cholesterol (mg/dL)(Baseline to Week 12)
- Change in HDL cholesterol (mg/dL)(Baseline to Week 12)
- Change in triglycerides (mg/dL)(Baseline to Week 12)
- Change in fasting blood glucose (mg/dL)(Baseline to Week 12)
- Change in urinary metabolite concentrations(Baseline to Week 12)
- Change in gut microbiota composition assessed by 16S rRNA sequencing(Baseline to Week 12)
- Change in quality of life assessed by validated questionnaire (SF-36)(Baseline to Week 12)
- Change in body weight (kg)(Baseline to Week 12)
- Change in body fat percentage (%)(Baseline to Week 12)
- Change in basal metabolic rate (kcal/day)(Baseline to Week 12)
研究者
Dr. Amjad Khan
Professor
Liaquat University of Medical & Health Sciences