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

NCT07189637 | Not Yet Recruiting

• 2 other identifiers: E-10840098-202.3.02-33172025/48
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; Cardiovascular diseases; DASH diet; Mediterranean diet; Intermittent fasting

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  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.

  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

Secondary Outcomes (19)

• 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

• 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

Study Arms (4)

Group A (control)

OTHER

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

Other: Face-to-face nutrition education

Group B (Intermittent Fasting Diet Group)

EXPERIMENTAL

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.

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

Group C (Mediterranean Diet Group)

EXPERIMENTAL

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

Other: Face-to-face nutrition education; Other: Mediterranean Diet

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

EXPERIMENTAL

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

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

Interventions

Face-to-face nutrition education OTHER

All participants will receive face-to-face nutrition education from specialist dietitians in accordance with the principles of nutrition for hypertension. Nutrition education will be provided through prepared brochures. The brochures will be given to participants as gifts. Nutrition education will cover topics such as hypertension and nutrition, nutrients, the importance of micronutrients, foods containing salt, reading labels, limiting salt consumption, healthy fat consumption, fibre consumption, water consumption, and healthy cooking methods.

Group A (control); Group B (Intermittent Fasting Diet Group); Group C (Mediterranean Diet Group); Group D (the Combination of Intermittent Fasting Diet and Mediterranean Diet)

Intermittent Fasting Diet OTHER

Training will be provided to all participants through a food and nutrition photo catalogue so that portions can be recorded correctly and within standard limits when keeping a food diary. Participants will restrict their food intake to a 16-hour period by applying the 16/8 Intermittent Fasting Diet model and will eat and drink whatever they want during the remaining 8 hours. During this 16-hour period, they will consume non-energy drinks consisting of water, unsweetened tea, unsweetened herbal teas and black coffee. It will be recommended that intermittent fasting be maintained from 6:00 p.m. to 10:00 a.m. However, participants may also choose other 16-hour periods, such as 7:00 p.m. to 11:00 a.m. or 8:00 p.m. to 12:00 p.m. Participants will be given a tracking chart to record the first and last times they consume food or energy-containing beverages during the day, and their adherence to the diet will be monitored based on their declarations.

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

Mediterranean Diet OTHER

Training will be provided to all participants through a food and nutrition photo catalogue to ensure that portions are recorded correctly and within standard limits when keeping a food diary. In addition, the dietician will provide this group with a diet plan calculated for energy, macro and micro nutrients, which will be different each week for the first four follow-ups. The diet plans provided will be prepared in accordance with the Mediterranean Diet food pyramid. Participants' energy requirements will be calculated using the Schofield Equation for basal metabolic rate, with adjustments made according to their physical activity levels. Energy requirements will be met by 45-50% from carbohydrates, 15-20% from protein, and 25-35% from fats.

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

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nadide Gizem Tarakci Filiz: lead
• Medipol University: collaborator
• Istanbul Medipol University Hospital: collaborator
• Fenerbahce University: collaborator

Study Sites (1)

Medipol Mega University Hospital

Istanbul, 34214, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Intermittent Fasting

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Vascular Diseases; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mehmet KOÇAK, PhD

  İstanbul Medipol Üniversitesi/Sağlık Bilim Ve Teknolojileri Araştırma Enstitüsü

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet KOÇAK, PhD

CONTACT

+90 530 097 75 33; mehmetkocak@medipol.edu.tr

Rüken Aslınur SAMANCI, MSc

CONTACT

+90 543 939 15 94; rasamanci@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 24, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)