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Cardiometabolic Risk Factors and Processed Food

The Relationship Between NOVA-Classified Processed Food Intake and Cardiometabolic Risk Factors in Türkiye

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06996262
Enrollment
236
Registered
2025-05-30
Start date
2024-03-01
Completion date
2024-04-30
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease, Cardiometabolic Diseases, Cardiometabolic Risk Factors, Cardiovascular Diseases, Nutrition, Nutritional Disease

Keywords

processed food, cardiometabolic risk, obesity, Framingham risk score

Brief summary

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.

Interventions

OTHERobservational study

The questionnaire consisted of structured questions covering sociodemographic information, health status, dietary habits, and physical activity levels.

Sponsors

Istanbul Bilgi University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* aged 18-65 years * volunteers patients

Exclusion criteria

* people under 18 years of ages * people over 65 years of ages * pregnant and breastfeeding women * individuals with active cancer or chronic illnesses

Design outcomes

Primary

MeasureTime frameDescription
Food Frequency RecordBaselineFood frequency records were taken to assess processed and ultra-processed food consumption according to the Nova classification.
Anthropometric Measurements - Waist/Height RatioBaselineWaist/height ratio was obtained by dividing waist circumference by height.
Anthropometric Measurements - Neck CircumferenceBaselineNeck 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.
Biochemical Measurements - Fasting blood glucoseBaselineFasting blood sugar (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse.
Biochemical Measurement - Lipid ProfileBaselineParticipants' 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.
Biochemical Measurements - HbA1CBaselineFasting 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.
Biochemical Measurements - Uric acidBaselineParticipants' 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.
Blood PressuresBaselineSystolic and Diastolic blood pressure (mmHg) includes auscultation of the brachial artery with a stethoscope to detect the appearance and muffled or absent Korotkoff sounds.
Framingham Risk ScoreBaselineThe 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.
Framingham Risk PercentageBaselineThe 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. * Low risk: Individuals with a score of less than 10%. This suggests a relatively low likelihood of experiencing a cardiovascular event within 10 years. * Moderate risk: Individuals with a score between 10% and 20%. * High risk: Individuals with a score above 20%.
Anthropometric Measurements - Body weight (kg)BaselineAt 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.
Anthropometric Measurements - HeightBaselineHeight (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Body Mass IndexBaselineThe body mass index (BMI) of the participants was calculated according to the body weight (kg) / height (m)2 formula.
Body Mass Index ClassificationBaselineThe 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.
Anthropometric Measurements - Waist circumferenceBaselineThe waist circumference was measured with a non-flexible tape measure at the midpoint between the lowest rib and the crystalline prominence.
Anthropometric Measurements - Hip circumferenceBaselineThe 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).
Anthropometric Measurements - Waist/Hip RatioBaselineWaist/hip ratio was obtained by dividing waist circumference by hip circumference.

Secondary

MeasureTime frameDescription
Physical Activity Levels ClassificationBaselinePhysical 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.
Physical Activity LevelsBaselineThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026