Effect of Nigella Sativa Oil Supplementation and Dietary Intervention on Lipid Profile in Overweight Adults with Hyperlipidemia: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Biochemical Measurements - fasting blood glucose
研究概览
简要总结
Hyperlipidemia is defined as an elevation of plasma cholesterol, lipid, or lipoprotein levels above normal due to abnormal fat metabolism or function, and individuals with hyperlipidemia are approximately twice as likely to develop cardiovascular disease. The first approach to treating hyperlipidemia is lifestyle changes, including dietary therapy and physical activity. In addition to traditional methods, treatments also include pharmacological interventions, and research on natural products and complementary therapies is increasing to increase the effectiveness of these treatment approaches. In this context, Nigella Sativa (NS) oil has emerged as a promising natural option in the treatment of hyperlipidemia and obesity in recent years.
The aim of this study was to examine the effects of NS oil supplementation given together with dietary intervention in individuals diagnosed with mild obesity.
The main questions it aims to answer are:
- Does Nigella Sativa supplementation improve blood lipid profiles in overweight or obese individuals?
- Does Nigella Sativa supplementation improve body composition in overweight or obese individuals?
Participants were individuals who were diagnosed with hyperlipidemia according to American Heart Association criteria as a result of medical evaluation by a cardiologist and who were deemed appropriate to use black seed oil supplements. Those who volunteered to participate in the study were included in the study.
The researchers are examining whether there is any effect on biochemical and anthropometric parameters by giving Nigella Sativa supplementation to a group in addition to a low-calorie diet for eight weeks.
详细描述
This research, which is a randomized controlled intervention study, was conducted between June 2023 and February 2024 with adult individuals with a BMI>25 kg/m2 who applied to the Cardiology Polyclinic of Karamürsel State Hospital and were referred to a nutrition and diet specialist after being diagnosed with hyperlipidemia according to AHA criteria by the physician.
Sample Selection and Randomization The sample size of the study was calculated using the G-Power 3.1.9 analysis program with a medium effect size (d=0.60), 90% power, α: 0.05 and 1-β: 0.95, with a minimum of 32 people in each group, 64 people were included. The 64 people who met the inclusion criteria were assigned to the intervention (n=32) and control (n=32) groups using the block randomization method, with similar age and gender.
Inclusion Criteria from the Study Individuals who were diagnosed with hyperlipidemia between the ages of 18-65, who did not have any serious comorbidities (kidney, liver and immune deficiency, oncological and psychiatric diseases), who were not pregnant or breastfeeding, who did not take any nutritional supplements including black seed, who did not have a known history of allergy to black seed and its products, who did not use medications that could interact with black seed oil (anticoagulant, antihypertensive, etc.), who did not use antilipidemic or anticholesterolemic medications, who did not do heavy exercise, who did not consume alcohol regularly and who did not have any special diet requirements were included in the study.
Data Collection Tools Research data were recorded using a questionnaire form, anthropometric measurements, biochemical tests and the IPAQ form.
Survey Form: Sociodemographic information, smoking and nutritional habits of the participants were recorded in the survey form.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults individuals who were diagnosed hyperlipidemia
- •Individuals suitable for taking Nigella satvia supplement
- •Individuals BMI>25 kg/m2
排除标准
- •Chronic liver disease,
- •Chronic kidney disease,
- •Heart failure, infarction or cerebrovascular disease,
- •Pregnant and breastfeeding women,
- •Severe psychiatric disorders,
- •Oncological diseases,
- •Individuals using medications that could interact with black seed oil (anticoagulant, antihypertensive, etc.)
- •Individuals using antilipidemic or anticholesterolemic medications
- •Individuals did not do heavy exercise
- •Individuals using any nutritional supplement
- •Individuals have a known history of allergy
- •Individuals did not consume alcohol regularly
- •Individuals with special dietary needs
结局指标
主要结局
Biochemical Measurements - fasting blood glucose
时间窗: 8 weeks
fasting blood glucose (mg/dL) were analyzed in the hospital biochemistry laboratory using routine methods at the beginning and end of the study from blood samples taken by a nurse
Biochemical Measurements - Liver Enzymes
时间窗: 8 weeks
Participants' liver enzymes tests (ALT and AST) (IU) were analyzed in the hospital biochemistry laboratory using routine methods at the beginning and end of the study from blood samples taken by a nurse after at least 12 hours of fasting and without consuming alcohol for 24 hours before.
Biochemical Measurement
时间窗: 8 weeks
Participants' biochemical tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, (mg/dL) were analyzed in the hospital biochemistry laboratory using routine methods at the beginning and end of the study from blood samples taken by a nurse after at least 12 hours of fasting and without consuming alcohol for 24 hours before.
Anthropometric Measurements - Body weight (kg)
时间窗: 8 weeks
At the beginning and end of the study, body weights (kg) were measured using a bioelectrical impedance (BIA) device (Tanita Perfecto) with a sensitivity of 50 grams in accordance with the measurement standards.
Anthropometric Measurements - Height
时间窗: 8 weeks
Height (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Body Mass Index
时间窗: 8 weeks
The body mass index (BMI) of the participants was calculated according to the body weight (kg) / height (m)2 formula.
Body Mass Index Classification
时间窗: 8 weeks
The body mass index (BMI) of the participants was classified according to the World Health Organization (WHO) criteria. BMI ≥ 25 kg/m2 was overweight and ≥ 30 kg/m2 was obese.
Anthropometric Measurements - Fat Mass
时间窗: 8 weeks
Body fat mass (kg) was analyzed using a bioelectrical impedance (BIA) device (Tanita Perfecto) at the beginning and end of the study, paying attention to measurement standards.
Anthropometric Measurements - Fat ratio calculation
时间窗: 8 weeks
At the beginning and end of the study, body composition analyses were performed using a bioelectrical impedance (BIA) device (Tanita Perfecto) with the measurement standards. According to the BIA analysis, fat ratio (%) was calculated as the ratio of total body fat weight to total body weight as a percentage.
Anthropometric Measurements - Waist circumference
时间窗: 8 weeks
At the beginning and end of the study, waist circumference were measured with a non-flexible tape measure at the midpoint between the lowest rib bone and the cristailiac crest.
Anthropometric Measurements - Fat-free mass
时间窗: 8 weeks
Fat-free mass (kg) was analyzed using a bioelectrical impedance (BIA) device (Tanita Perfecto) at the beginning and end of the study, paying attention to measurement standards.
Anthropometric Measurements - Muscle mass
时间窗: 8 weeks
Muscle mass (kg) was analyzed using a bioelectrical impedance (BIA) device (Tanita Perfecto) at the beginning and end of the study, paying attention to measurement standards.
Anthropometric Measurements - Total body water
时间窗: 8 weeks
Total body water (kg) was analyzed using a bioelectrical impedance (BIA) device (Tanita Perfecto) at the beginning and end of the study, paying attention to measurement standards.
Anthropometric Measurements - Hip circumference
时间窗: 8 weeks
At the beginning and end of the study, in measuring hip circumference, the individual was asked to stand upright with their arms at their sides and their feet side by side. Frankfort plane was provided. The individual stood on their right side. The highest point on the hip (from the side) was determined and the circumference was measured with a tape measure.
Anthropometric Measurements - Neck circumference
时间窗: 8 weeks
At the beginning and end of the study, neck circumference measurement was made with a tape measure just below the laryngeal prominence (Adam's apple).
Anthropometric Measurements - Waist/Height Ratio
时间窗: 8 weeks
At the beginning and end of the study, waist/height ratio was obtained by dividing waist circumference by height.
Anthropometric Measurements - Waist/Hip Ratio
时间窗: 8 weeks
Waist/hip ratio was obtained by dividing waist circumference by hip circumference.
次要结局
- Physical Activity(1 week)
研究者
Hande Seven Avuk
Head of Nutrition and Dietetics Department
Istanbul Bilgi University