Cardiometabolic Risk Factors and Processed Food

Completed

• Conditions: Cardiac Disease; Cardiovascular Diseases; Nutrition; Cardiometabolic Diseases; Nutritional Disease; Cardiometabolic Risk Factors

• Registration Number: NCT06996262
• Lead Sponsor: Istanbul Bilgi University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anthropometric Measurements - Waist/Hip Ratio	Baseline	Waist/hip ratio was obtained by dividing waist circumference by hip circumference.
Body Mass Index Classification	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.
Biochemical Measurements - Fasting blood glucose	Baseline	Fasting 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 Profile	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.
Biochemical Measurements - HbA1C	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.
Biochemical Measurements - Uric acid	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.
Blood Pressures	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.
Framingham Risk Score	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.
Framingham Risk Percentage	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.; * 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)	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.
Anthropometric Measurements - Height	Baseline	Height (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Anthropometric Measurements - Waist circumference	Baseline	The waist circumference was measured with a non-flexible tape measure at the midpoint between the lowest rib and the crystalline prominence.
Anthropometric Measurements - Hip circumference	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).
Anthropometric Measurements - Waist/Height Ratio	Baseline	Waist/height ratio was obtained by dividing waist circumference by height.
Anthropometric Measurements - Neck Circumference	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.
Body Mass Index	Baseline	The body mass index (BMI) of the participants was calculated according to the body weight (kg) / height (m)2 formula.
Food Frequency Record	Baseline	Food frequency records were taken to assess processed and ultra-processed food consumption according to the Nova classification.

Secondary Outcome Measures

Name	Time	Method
Physical Activity Levels	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.
Physical Activity Levels Classification	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.

Trial Locations

Locations (1)

Istanbul Bilgi University; 🇹🇷 Istanbul, Turkey