The Combined Effect of the Mediterranean Diet and Intermittent Fasting on Hypertension
NCT ID: NCT07189637
Last Updated: 2025-09-24
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
48 participants
INTERVENTIONAL
2025-11-01
2026-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A (control)
Participants will only receive face-to-face nutrition education.
Face-to-face nutrition education
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 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.
Face-to-face nutrition education
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.
Intermittent Fasting Diet
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 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
Face-to-face nutrition education
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.
Mediterranean Diet
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 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
Face-to-face nutrition education
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.
Intermittent Fasting Diet
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.
Mediterranean Diet
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.
Interventions
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Face-to-face nutrition education
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.
Intermittent Fasting Diet
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.
Mediterranean Diet
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
65 Years
ALL
No
Sponsors
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Medipol University
OTHER
Istanbul Medipol University Hospital
OTHER
Fenerbahce University
OTHER
Nadide Gizem Tarakci Filiz
OTHER
Responsible Party
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Nadide Gizem Tarakci Filiz
Asst. Prof.
Principal Investigators
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Mehmet KOÇAK, PhD
Role: PRINCIPAL_INVESTIGATOR
İstanbul Medipol Üniversitesi/Sağlık Bilim Ve Teknolojileri Araştırma Enstitüsü
Locations
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Medipol Mega University Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2025/48
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
E-10840098-202.3.02-3317
Identifier Type: -
Identifier Source: org_study_id
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