NCT Number: NCT07189637
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.
Trial opening soon.
Get Notified40 year–65 year
All sexes
Interventional
Not applicable
Istanbul, 34214, Turkey (Türkiye)
Aysel AKHUNDOVA, Dr.
CONTACT
Aysel AKHUNDOVA, Dr.
SUB_INVESTIGATOR
Emre BAYRAKTAROĞLU, PhD
SUB_INVESTIGATOR
Mehmet KOÇAK, PhD
CONTACT
Mehmet KOÇAK, PhD
PRINCIPAL_INVESTIGATOR
Nadide Gizem TARAKÇI FİLİZ, PhD
SUB_INVESTIGATOR
Nihal Zekiye ERDEM, PhD
SUB_INVESTIGATOR
Rüken Aslınur SAMANCI, MSc
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be excluded if they have any of the following:
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.
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.
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: 70-99 mg/dL
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: < 5.7% (normal), 5.7-6.4% (prediabetes), ≥ 6.5% (diabetes)
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: 2-25 µU/mL
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: < 150 mg/dL
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values:
Men: ≥ 40 mg/dL Women: ≥ 50 mg/dL
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: < 100 mg/dL
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: < 200 mg/dL
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: 7-20 mg/dL
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values:
Men: 0.7-1.3 mg/dL Women: 0.6-1.1 mg/dL
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: 135-145 mmol/L
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: 3.5-5.0 mmol/L
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
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)
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: Men: < 41 U/L; Women: < 31 U/L
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: Men: < 40 U/L; Women: < 32 U/L
Time frame: At enrollment, 13 weeks later than enrollment, 26 weeks later than enrollment
This will be obtained from blood tests. Reference values: Men: 8-61 U/L; Women: 5-36 U/L
Contact information is provided by the study sponsor or research team.
Mehmet KOÇAK, PhD
CONTACT
Rüken Aslınur SAMANCI, MSc
CONTACT
Nadide Gizem Tarakci Filiz
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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