The Combined Effect of the Mediterranean Diet and Intermittent Fasting on Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Blood pressure
研究概览
简要总结
Hypertension (HT) is an important risk factor for cardiovascular diseases (CVD) and death. Approximately 16.9 million people in Turkey have HT. Nutritional habits play an important role in the development of HT. DASH (Dietary Approaches to Stop Hypertension) and the Mediterranean diet (MD) have been found to be effective in lowering blood pressure and reducing cardiometabolic risks. The DASH diet stands out with its low sodium, saturated fat, simple sugar and cholesterol content, while it is rich in fiber, potassium, magnesium and anti-inflammatory components. The MD is based on healthy foods such as olive oil, vegetables, fruits, fish and nuts, and contains antioxidants and healthy fatty acids. This study will investigate whether the sodium-restricted MD can offer a model comparable to DASH. In addition, the effects of the intermittent fasting diet (IFD) model alone and in combination with the MD on blood pressure will be examined. It has been observed that IFD reduces blood pressure by reducing energy intake and acting on the autonomic nervous system. The aim of this project is to evaluate the effects of MD, IFD and both of them on hypertension and to present a new and original approach in this field.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed hypertension patients
- •Individuals with blood pressure >140/90 mmHg
- •Individuals with a body mass index (BMI) in the range of 18.5-25 kg/m²
- •Individuals aged 40-65 years
排除标准
- •Participants will be excluded if they have any of the following:
- •Type 2 Diabetes Mellitus
- •Type 1 Diabetes Mellitus
- •Cardiovascular disease
- •Liver disease
- •Kidney disease
- •Gastrointestinal disease
- •Respiratory disease
- •Psychiatric disorders
- •Women who are pregnant or breastfeeding
- •Severe food allergies
- •Current smokers or individuals consuming alcohol regularly
- •History of major surgery within the last 6 months
研究组 & 干预措施
Group B (Intermittent Fasting Diet Group)
Participants will receive face-to-face nutrition education and Intermittent Fasting Diet. Additionally, a brochure package containing information about Intermittent Fasting Diet models will be prepared by a dietitian and distributed to participants by the same dietitian along with the training.
干预措施: Face-to-face nutrition education (Other)
Group B (Intermittent Fasting Diet Group)
Participants will receive face-to-face nutrition education and Intermittent Fasting Diet. Additionally, a brochure package containing information about Intermittent Fasting Diet models will be prepared by a dietitian and distributed to participants by the same dietitian along with the training.
干预措施: Intermittent Fasting Diet (Other)
Group C (Mediterranean Diet Group)
Participants will receive face-to-face nutrition education and Mediterranean Diet. Additionally, a brochure package containing information about Mediterranean Diet models will be prepared by a dietitian and distributed to participants by the same dietitian along with the training.
Three separate packages compliant with the Mediterranean Diet will be given at the start of the study, 2nd week and 4th week.
Package 1: 250 mL natural extra virgin olive oil, 150 g walnuts, 1 avocado, 250 g black raisins, 1 L semi-skimmed UHT cow's milk, 1 kg green lentils and 1 garlic clove Package 2: 250 mL of natural extra virgin olive oil, 200 g of raw hazelnuts, 150-200 g of unsalted black olives, 140 g of dried apricots, 1 L of semi-skimmed UHT cow's milk, 1 kg of dried beans, and 700 g of unsalted tomato paste Package 3: 250 mL extra virgin olive oil, 180 g unsalted pumpkin seeds, 1 kg apples, 1 L semi-skimmed UHT cow's milk, 500 g whole wheat pasta and 500 g red lentils
干预措施: Face-to-face nutrition education (Other)
Group C (Mediterranean Diet Group)
Participants will receive face-to-face nutrition education and Mediterranean Diet. Additionally, a brochure package containing information about Mediterranean Diet models will be prepared by a dietitian and distributed to participants by the same dietitian along with the training.
Three separate packages compliant with the Mediterranean Diet will be given at the start of the study, 2nd week and 4th week.
Package 1: 250 mL natural extra virgin olive oil, 150 g walnuts, 1 avocado, 250 g black raisins, 1 L semi-skimmed UHT cow's milk, 1 kg green lentils and 1 garlic clove Package 2: 250 mL of natural extra virgin olive oil, 200 g of raw hazelnuts, 150-200 g of unsalted black olives, 140 g of dried apricots, 1 L of semi-skimmed UHT cow's milk, 1 kg of dried beans, and 700 g of unsalted tomato paste Package 3: 250 mL extra virgin olive oil, 180 g unsalted pumpkin seeds, 1 kg apples, 1 L semi-skimmed UHT cow's milk, 500 g whole wheat pasta and 500 g red lentils
干预措施: Mediterranean Diet (Other)
Group D (the Combination of Intermittent Fasting Diet and Mediterranean Diet)
Participants will receive face-to-face nutrition education and the combination of IFD and MD. Additionally, a brochure package containing information about IFD and MD models will be prepared by a dietitian and distributed to participants by the same dietitian along with the training.
Three separate packages compliant with the MD will be given at the start of the study, 2nd week and 4th week.
Pkg. 1: 250 mL natural extra virgin olive oil, 150 g walnuts, 1 avocado, 250 g black raisins, 1 L semi-skimmed UHT cow's milk, 1 kg green lentils and 1 garlic clove Pkg. 2: 250 mL of natural extra virgin olive oil, 200 g of raw hazelnuts, 150-200 g of unsalted black olives, 140 g of dried apricots, 1 L of semi-skimmed UHT cow's milk, 1 kg of dried beans, and 700 g of unsalted tomato paste Pkg. 3: 250 mL extra virgin olive oil, 180 g unsalted pumpkin seeds, 1 kg apples, 1 L semi-skimmed UHT cow's milk, 500 g whole wheat pasta and 500 g red lentils
干预措施: Face-to-face nutrition education (Other)
Group D (the Combination of Intermittent Fasting Diet and Mediterranean Diet)
Participants will receive face-to-face nutrition education and the combination of IFD and MD. Additionally, a brochure package containing information about IFD and MD models will be prepared by a dietitian and distributed to participants by the same dietitian along with the training.
Three separate packages compliant with the MD will be given at the start of the study, 2nd week and 4th week.
Pkg. 1: 250 mL natural extra virgin olive oil, 150 g walnuts, 1 avocado, 250 g black raisins, 1 L semi-skimmed UHT cow's milk, 1 kg green lentils and 1 garlic clove Pkg. 2: 250 mL of natural extra virgin olive oil, 200 g of raw hazelnuts, 150-200 g of unsalted black olives, 140 g of dried apricots, 1 L of semi-skimmed UHT cow's milk, 1 kg of dried beans, and 700 g of unsalted tomato paste Pkg. 3: 250 mL extra virgin olive oil, 180 g unsalted pumpkin seeds, 1 kg apples, 1 L semi-skimmed UHT cow's milk, 500 g whole wheat pasta and 500 g red lentils
干预措施: Intermittent Fasting Diet (Other)
Group D (the Combination of Intermittent Fasting Diet and Mediterranean Diet)
Participants will receive face-to-face nutrition education and the combination of IFD and MD. Additionally, a brochure package containing information about IFD and MD models will be prepared by a dietitian and distributed to participants by the same dietitian along with the training.
Three separate packages compliant with the MD will be given at the start of the study, 2nd week and 4th week.
Pkg. 1: 250 mL natural extra virgin olive oil, 150 g walnuts, 1 avocado, 250 g black raisins, 1 L semi-skimmed UHT cow's milk, 1 kg green lentils and 1 garlic clove Pkg. 2: 250 mL of natural extra virgin olive oil, 200 g of raw hazelnuts, 150-200 g of unsalted black olives, 140 g of dried apricots, 1 L of semi-skimmed UHT cow's milk, 1 kg of dried beans, and 700 g of unsalted tomato paste Pkg. 3: 250 mL extra virgin olive oil, 180 g unsalted pumpkin seeds, 1 kg apples, 1 L semi-skimmed UHT cow's milk, 500 g whole wheat pasta and 500 g red lentils
干预措施: Mediterranean Diet (Other)
Group A (control)
Participants will only receive face-to-face nutrition education.
干预措施: Face-to-face nutrition education (Other)
结局指标
主要结局
Blood pressure
时间窗: At enrollment, 1 week later than enrollment, 2 weeks later than enrollment, 3 weeks later than enrollment, 4 weeks later than enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
The participants' blood pressure will be measured six times in this research. Blood pressure measurements will be taken by a trained physician in accordance with standard measurement protocols. Measurements will be taken after a 5-minute rest period, with the patient seated, using an automatic blood pressure monitor with the correct cuff size applied to the arm. Two consecutive measurements will be taken for each patient, with at least 1 minute between measurements. The average of the two measurements obtained will be used in the analyses. The following points will be taken into consideration during the measurements. * Patients should not have smoked, consumed caffeine, or exercised in the last 30 minutes * During the measurement, the patient should be leaning back with their feet flat on the floor * The arm being measured should be supported at heart level Blood pressure values will be evaluated according to the 2023 ESC/ESH hypertension guidelines.
次要结局
- AST in U/L(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- GGT in U/L(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Body Mass Index (BMI) in kg/m²(At enrollment, 1 week later than enrollment, 2 weeks later than enrollment, 3 weeks later than enrollment, 4 weeks later than enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Waist circumference in cm(At enrollment, 1 week later than enrollment, 2 weeks later than enrollment, 3 weeks later than enrollment, 4 weeks later than enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Fasting plasma glucose in mg/dL(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- HbA1c in %(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Insulin in µU/mL(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Triglycerides in mg/dL(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- HDL cholesterol in mg/dL(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- LDL cholesterol in mg/dL(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Total cholesterol in mg/dL(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Urea in mg/dL(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Creatinine in mg/dL(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Sodium in mmol/L(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Potassium in mmol/L(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- hs-CRP in mg/L(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- ALT in U/L(At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Height in cm(At enrollment, 1 week later than enrollment, 2 weeks later than enrollment, 3 weeks later than enrollment, 4 weeks later than enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
- Body weight in kg(At enrollment, 1 week later than enrollment, 2 weeks later than enrollment, 3 weeks later than enrollment, 4 weeks later than enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment)
研究者
Nadide Gizem Tarakci Filiz
Asst. Prof.
Fenerbahce University