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HypertensionNCT07189637

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

A study testing Face-to-face nutrition education, Intermittent Fasting Diet and Mediterranean Diet in people with Hypertension, run by Nadide Gizem Tarakci Filiz at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Hypertension
What is being tested?
Face-to-face nutrition education, Intermittent Fasting Diet and Mediterranean Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
13 Dec 2025to 15 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Turkey (Türkiye)1 site, 1 recruiting

  • Medipol Mega University Hospital

    Istanbul, 34214

    Aysel AKHUNDOVA, Dr., +90 541 858 62 01, aysel.akhundova@medipol.edu.tr

    Mehmet KOÇAK, PhD, +90 530 097 75 33, mehmetkocak@medipol.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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
Being tested
Face-to-face nutrition education, Intermittent Fasting Diet, Mediterranean Diet
Keywords
Hypertension, Cardiovascular diseases, DASH diet, Mediterranean diet, Intermittent fasting
Medical subject headings
Hypertension, Cardiovascular Diseases, Intermittent Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Face-to-face nutrition educationOther

    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 DietOther

    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 DietOther

    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.

Study groups in NCT07189637
Study groupRoleWhat they receive
Group A (control)OtherParticipants will only receive face-to-face nutrition education.
Receives: Other: Face-to-face nutrition education
Group B (Intermittent Fasting Diet Group)ExperimentalParticipants 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.
Receives: Other: Face-to-face nutrition education; Other: Intermittent Fasting Diet
Group C (Mediterranean Diet Group)ExperimentalParticipants 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
Receives: Other: Face-to-face nutrition education; Other: Mediterranean Diet
Group D (the Combination of Intermittent Fasting Diet and Mediterranean Diet)ExperimentalParticipants 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
Receives: Other: Face-to-face nutrition education; Other: Intermittent Fasting Diet; Other: Mediterranean Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Height in cm

    Height measurement will be taken by a specialist dietician. It will be performed in accordance with the measurement techniques and standards recommended by the International Society for the Advancement of Kinanthropometry. Participants' heights will be measured barefoot using a stadiometer with an accuracy of 0.01 m.

    Measured: 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

  2. Body weight in kg

    Body weight measurement will be taken by a specialist dietician. It will be performed in accordance with the measurement techniques and standards recommended by the International Society for the Advancement of Kinanthropometry. Body weight and body composition will be measured using a body composition analyser with a precision of 0.1 kg. The participants' clothing weight (1.0 kg) will be recorded on the analyser before measurement. Measurements will be taken barefoot and with participants wearing light clothing. Metal objects on participants will be removed.

    Measured: 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

  3. Body Mass Index (BMI) in kg/m²

    Body Mass Index (BMI) will be used to assess whether an individual's body weight is appropriate for their height. It is calculated by dividing a person's body weight, measured in kilograms (kg), by the square of their height, measured in meters (m). Since height will be measured in centimeters (cm), it will first be converted into meters. This will be done by dividing the height in centimeters by 100.

    Measured: 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

  4. Waist circumference in cm

    Waist circumference: Waist circumference will be taken by a specialist dietician. It will be measured at the narrowest point of the waist with the individual standing upright and without any clothing around the waist. Measurements will be taken with a tape measure, ensuring it is in contact with the skin without applying excessive pressure.

    Measured: 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

  5. Fasting plasma glucose in mg/dL

    This will be obtained from blood tests. Reference values: 70-99 mg/dL

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  6. HbA1c in %

    This will be obtained from blood tests. Reference values: < 5.7% (normal), 5.7-6.4% (prediabetes), ≥ 6.5% (diabetes)

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  7. Insulin in µU/mL

    This will be obtained from blood tests. Reference values: 2-25 µU/mL

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  8. Triglycerides in mg/dL

    This will be obtained from blood tests. Reference values: < 150 mg/dL

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  9. HDL cholesterol in mg/dL

    This will be obtained from blood tests. Reference values:

    Men: ≥ 40 mg/dL Women: ≥ 50 mg/dL

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  10. LDL cholesterol in mg/dL

    This will be obtained from blood tests. Reference values: < 100 mg/dL

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  11. Total cholesterol in mg/dL

    This will be obtained from blood tests. Reference values: < 200 mg/dL

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  12. Urea in mg/dL

    This will be obtained from blood tests. Reference values: 7-20 mg/dL

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  13. Creatinine in mg/dL

    This will be obtained from blood tests. Reference values:

    Men: 0.7-1.3 mg/dL Women: 0.6-1.1 mg/dL

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  14. Sodium in mmol/L

    This will be obtained from blood tests. Reference values: 135-145 mmol/L

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  15. Potassium in mmol/L

    This will be obtained from blood tests. Reference values: 3.5-5.0 mmol/L

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  16. hs-CRP in mg/L

    This will be obtained from blood tests. Reference values: < 1 mg/L (low cardiovascular risk), 1-3 mg/L (intermediate risk), > 3 mg/L (high risk)

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  17. ALT in U/L

    This will be obtained from blood tests. Reference values: Men: < 41 U/L; Women: < 31 U/L

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  18. AST in U/L

    This will be obtained from blood tests. Reference values: Men: < 40 U/L; Women: < 32 U/L

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

  19. GGT in U/L

    This will be obtained from blood tests. Reference values: Men: 8-61 U/L; Women: 5-36 U/L

    Measured: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start13 Dec 2025
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07189637
Sponsor's protocol ID
E-10840098-202.3.02-3317
Other IDs
2025/48
Status last verified
Sep 2026
First submitted
13 Sep 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Filippou C, Thomopoulos C, Konstantinidis D, Siafi E, Tatakis F, Manta E, Drogkaris S, Polyzos D, Kyriazopoulos K, Grigoriou K, Tousoulis D, Tsioufis K. DASH vs. Mediterranean diet on a salt restriction background in adults with high normal blood pressure or grade 1 hypertension: A randomized controlled trial. Clin Nutr. 2023 Oct;42(10):1807-1816. doi: 10.1016/j.clnu.2023.08.011. Epub 2023 Aug 18.

    PubMed 37625311

  • Zou Y, Tang J, Zhang F, Chen D, Mu L, Xu H, Yu P, Ren Y, Mei Y, Mu L. Effect of low-sodium salt applied to Chinese modified DASH diet on arterial stiffness in older patients with hypertension and type 2 diabetes. Nutr Hosp. 2023 Oct 6;40(5):967-974. doi: 10.20960/nh.04622.

    PubMed 37534516

  • Zhou X, Lin X, Yu J, Yang Y, Muzammel H, Amissi S, Schini-Kerth VB, Lei X, Jose PA, Yang J, Shi D. Effects of DASH diet with or without time-restricted eating in the management of stage 1 primary hypertension: a randomized controlled trial. Nutr J. 2024 Jun 17;23(1):65. doi: 10.1186/s12937-024-00967-9.

    PubMed 38886740

  • Zhou B, Perel P, Mensah GA, Ezzati M. Global epidemiology, health burden and effective interventions for elevated blood pressure and hypertension. Nat Rev Cardiol. 2021 Nov;18(11):785-802. doi: 10.1038/s41569-021-00559-8. Epub 2021 May 28.

    PubMed 34050340

  • Guideline: Sodium Intake for Adults and Children. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK133309/

    PubMed 23658998

  • World Health Organization (WHO). "Obesity and overweight". https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Last access: 12.02.2024

  • Valenzuela-Fuenzalida JJ, Bravo VS, Valarezo LM, Delgado Retamal MF, Leiva JM, Bruna-Mejias A, Nova-Baeza P, Orellana-Donoso M, Suazo-Santibanez A, Oyanedel-Amaro G, Gutierrez-Espinoza H. Effectiveness of DASH Diet versus Other Diet Modalities in Patients with Metabolic Syndrome: A Systematic Review and Meta-Analysis. Nutrients. 2024 Sep 10;16(18):3054. doi: 10.3390/nu16183054.

    PubMed 39339654

  • Urquiaga I, Echeverria G, Dussaillant C, Rigotti A. [Origin, components and mechanisms of action of the Mediterranean diet]. Rev Med Chil. 2017 Jan;145(1):85-95. doi: 10.4067/S0034-98872017000100012. Spanish.

    PubMed 28393974

  • The International Society for the Advancement of Kinanthropometry. www.isak.global. Last access: 03.11.2023

  • Stekovic S, Hofer SJ, Tripolt N, Aon MA, Royer P, Pein L, Stadler JT, Pendl T, Prietl B, Url J, Schroeder S, Tadic J, Eisenberg T, Magnes C, Stumpe M, Zuegner E, Bordag N, Riedl R, Schmidt A, Kolesnik E, Verheyen N, Springer A, Madl T, Sinner F, de Cabo R, Kroemer G, Obermayer-Pietsch B, Dengjel J, Sourij H, Pieber TR, Madeo F. Alternate Day Fasting Improves Physiological and Molecular Markers of Aging in Healthy, Non-obese Humans. Cell Metab. 2019 Sep 3;30(3):462-476.e6. doi: 10.1016/j.cmet.2019.07.016. Epub 2019 Aug 27.

    PubMed 31471173

  • McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; A.S.P.E.N. Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):277-316. doi: 10.1177/0148607109335234. No abstract available.

    PubMed 19398613

  • Schwingshackl L, Hoffmann G. Mediterranean dietary pattern, inflammation and endothelial function: a systematic review and meta-analysis of intervention trials. Nutr Metab Cardiovasc Dis. 2014 Sep;24(9):929-39. doi: 10.1016/j.numecd.2014.03.003. Epub 2014 Apr 2.

    PubMed 24787907

  • Schofield WN. Predicting basal metabolic rate, new standards and review of previous work. Hum Nutr Clin Nutr. 1985;39 Suppl 1:5-41.

    PubMed 4044297

  • Saulle, R., La Torre, G. 2010. "The Mediterranean Diet, recognized by UNESCO as a cultural heritage of humanity", Italian Journal of Public Health, 7(4).

  • Sacks FM, Campos H. Dietary therapy in hypertension. N Engl J Med. 2010 Jun 3;362(22):2102-12. doi: 10.1056/NEJMct0911013. No abstract available.

    PubMed 20519681

Questions about this trial

What is this clinical trial studying?

A study testing Face-to-face nutrition education, Intermittent Fasting Diet and Mediterranean Diet in people with Hypertension, run by Nadide Gizem Tarakci Filiz at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehmet KOÇAK, PhD (+90 530 097 75 33, mehmetkocak@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07189637, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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