Istanbul Bilgi University
Istanbul, Turkey (Türkiye)
NCT Number: NCT06996262
Cardiovascular diseases (CVD) remain a primary cause of chronic disability and mortality globally, with cardiometabolic risk factors such as hypertension, dyslipidemia, obesity, and diabetes significantly contributing to their development. Poor nutrition is recognized as a modifiable key risk factor for CVD, representing a crucial area for prevention strategies. While current research often emphasizes overall dietary patterns and quality in CVD prevention, the spectrum of food processing, ranging from minimally processed to ultra-processed foods (UPFs), can profoundly influence diet quality.
Ultra-processed foods, characterized by industrial processing techniques, additives, and special industrial ingredients, have been shown to potentially compromise the health benefits of food by reducing essential nutrients and bioactive compounds, introducing unhealthy elements, and altering food structures. Emerging epidemiological evidence links higher UPF consumption to an increased risk of obesity, hypertension, metabolic syndrome, and type 2 diabetes, with studies like the Framingham Offspring Study indicating a positive association with CVD incidence.
Globally, UPF consumption is on the rise, constituting a significant portion of daily energy intake. In Turkey, data from the 2021 National Nutrition and Health Survey reveals that a substantial 58% of adults consume processed foods daily . This is particularly concerning given Turkey's high burden of CVD, which has been the leading cause of mortality for decades and is projected to increase further due to an aging population and rising rates of diabetes and obesity. Notably, Turkey has the highest rate of early myocardial infarction in Europe.
Given the increasing consumption of UPFs and their potential health implications, especially in a country with a high prevalence of CVD like Turkey, understanding the relationship between dietary factors and cardiovascular health is critical. Therefore, this study aims to investigate the association between processed food intake and cardiometabolic risk factors among adult individuals in Türkiye.
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Notify Me18 year–65 year
All sexes
Observational
Istanbul, Turkey (Türkiye)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The questionnaire consisted of structured questions covering sociodemographic information, health status, dietary habits, and physical activity levels.
Time frame: Baseline
Fasting blood sugar (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse.
Time frame: Baseline
Participants' biochemical tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, (mg/dL) were analyzed in the hospital biochemistry laboratory using routine methods at the beginning of the study from blood samples taken by a nurse after at least 12 hours of fasting and without consuming alcohol for 24 hours before.
Time frame: Baseline
Fasting blood sugar (mg/dL) was analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse at the beginning of the study.
Time frame: Baseline
Participants' serum uric acid tests (mg/dL) was analyzed in the hospital biochemistry laboratory using routine methods at the beginning of the study from blood samples taken by a nurse after at least 12 hours of fasting and without consuming alcohol for 24 hours before.
Time frame: Baseline
Systolic and Diastolic blood pressure (mmHg) includes auscultation of the brachial artery with a stethoscope to detect the appearance and muffled or absent Korotkoff sounds.
Time frame: Baseline
The Framingham Risk Score was used to assess the risk of cardiovascular disease (CVD) in participants. To evaluate the 10-year risk of cardiovascular events, the following variables were considered: age, gender, total cholesterol, HDL cholesterol, systolic and diastolic blood pressure, smoking status, and diabetes. Each variable is assigned a specific score, and the total score for each participant is calculated by summing these. A higher score indicates a greater cardiometabolic risk.
Time frame: Baseline
The total Framinham risk score estimates the probability of experiencing a cardiovascular event within 10 years, and the resulting percentage values are classified into low, moderate, and high risk categories.
Time frame: Baseline
At the beginning of the study, body weights (kg) was measured using a calibrated portable digital scale with a sensitivity of 50 grams in accordance with the measurement standards.
Time frame: Baseline
Height (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Time frame: Baseline
The body mass index (BMI) of the participants was calculated according to the body weight (kg) / height (m)2 formula.
Time frame: Baseline
The body mass index (BMI) of the participants is classified according to the World Health Organization (WHO) criteria. BMI ≤ 18.5 kg/m2 is underweight, between 18.5-24.99 kg/m2 is normal, ≥ 25 kg/m2 is overweight, and ≥ 30 kg/m2 is obese.
Time frame: Baseline
The waist circumference was measured with a non-flexible tape measure at the midpoint between the lowest rib and the crystalline prominence.
Time frame: Baseline
The individual was asked to stand upright with their arms at their sides and their feet side by side when measuring hip circumference. The Frankfort plane was provided. The individual was measured with a tape measure from the right side, determining the highest point of the hip (from the side).
Time frame: Baseline
Waist/hip ratio was obtained by dividing waist circumference by hip circumference.
Time frame: Baseline
Waist/height ratio was obtained by dividing waist circumference by height.
Time frame: Baseline
Neck circumference (cm) was measured at the level of the laryngeal prominence using a flexible tape measure, with participants standing, their heads upright and their eyes looking straight ahead.
Time frame: Baseline
Food frequency records were taken to assess processed and ultra-processed food consumption according to the Nova classification.
Time frame: Baseline
The International Physical Activity Questionnaire (IPAQ) Short Form, developed by Craig et al. and whose Turkish validity and reliability study was conducted by Öztürk, were used to assess the physical activity levels of the participants. In the IPAQ short form (7 questions) assessment, the energy required for activities will be calculated with the Metabolic Equivalent Task minutes per week (MET-minutes) score. The calculation of the total score includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity activity and vigorous activity.
Time frame: Baseline
Physical activity will be classified into 3 groups according to MET value. The physically inactive group is determined as those below 600 MET-min/week, moderately active between 600-3000 MET-min/week, active above 3000 MET-min/week, very active above 1500 MET-min/week and at least 3 days of vigorous activity or above 3000 MET-min/week and at least 7 days of walking.
Istanbul Bilgi University
Other
The Relationship Between NOVA-Classified Processed Food Intake and Cardiometabolic Risk Factors in Türkiye
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