The Combined Effect of the Mediterranean Diet and Intermittent Fasting on Hypertension

Nadide Gizem Tarakci Filiz

Status: Not yet enrolling

Conditions: Hypertension

Treatments: Other: Face-to-face nutrition education; Other: Mediterranean Diet; Other: Intermittent Fasting Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07189637

2025/48 (Other Grant/Funding Number)

E-10840098-202.3.02-3317

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 4 patient groups

Group A (control)

Other group

Description:

Participants will only receive face-to-face nutrition education.

Treatment:

Other: Face-to-face nutrition education

Group B (Intermittent Fasting Diet Group)

Experimental group

Description:

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.

Treatment:

Other: Intermittent Fasting Diet

Other: Face-to-face nutrition education

Group C (Mediterranean Diet Group)

Experimental group

Description:

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

Treatment:

Other: Mediterranean Diet

Other: Face-to-face nutrition education

Group D (the Combination of Intermittent Fasting Diet and Mediterranean Diet)

Experimental group

Description:

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

Treatment:

Other: Mediterranean Diet

Other: Intermittent Fasting Diet

Other: Face-to-face nutrition education