Cardiometabolic Risk Factors and Processed Food

NCT06996262 | Completed

• 1 other identifier: ULTRAHEARTTR
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

processed food; cardiometabolic risk; obesity; Framingham risk score

Outcome Measures

Primary Outcomes (17)

• Biochemical Measurements - Fasting blood glucose

  Fasting blood sugar (mg/dL) will be analyzed in the hospital biochemistry laboratory using routine methods from blood samples taken by a nurse.

  Baseline

• Biochemical Measurement - Lipid Profile

  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.

  Baseline

• Biochemical Measurements - HbA1C

  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.

  Baseline

• Biochemical Measurements - Uric acid

  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.

  Baseline

• Blood Pressures

  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.

  Baseline

• Framingham Risk Score

  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.

  Baseline

• Framingham Risk Percentage

  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%.

  Baseline

• Anthropometric Measurements - Body weight (kg)

  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.

  Baseline

• Anthropometric Measurements - Height

  Height (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright.

  Baseline

• Body Mass Index

  The body mass index (BMI) of the participants was calculated according to the body weight (kg) / height (m)2 formula.

  Baseline

• Body Mass Index Classification

  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.

  Baseline

• Anthropometric Measurements - Waist circumference

  The waist circumference was measured with a non-flexible tape measure at the midpoint between the lowest rib and the crystalline prominence.

  Baseline

• Anthropometric Measurements - Hip circumference

  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).

  Baseline

• Anthropometric Measurements - Waist/Hip Ratio

  Waist/hip ratio was obtained by dividing waist circumference by hip circumference.

  Baseline

• Anthropometric Measurements - Waist/Height Ratio

  Waist/height ratio was obtained by dividing waist circumference by height.

  Baseline

• Anthropometric Measurements - Neck Circumference

  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.

  Baseline

• Food Frequency Record

  Food frequency records were taken to assess processed and ultra-processed food consumption according to the Nova classification.

  Baseline

Secondary Outcomes (2)

• Physical Activity Levels

  Baseline

• Physical Activity Levels Classification

  Baseline

Study Arms (1)

Observational Study Group

* Aged 18-65, * Volunteers at the Zonguldak Atatürk State Hospital * Outpatients applying to the internal medicine polyclinic

Other: observational study

Interventions

observational study OTHER

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

Observational Study Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients applying to the internal medicine polyclinic

You may qualify if:

• aged 18-65 years
• volunteers patients

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Istanbul Bilgi University

Istanbul, Turkey (Türkiye)

Location

Related Publications (8)

• Tokgozoglu L, Kayikcioglu M, Ekinci B. The landscape of preventive cardiology in Turkey: Challenges and successes. Am J Prev Cardiol. 2021 Apr 14;6:100184. doi: 10.1016/j.ajpc.2021.100184. eCollection 2021 Jun.

  PMID: 34327504 BACKGROUND

• Hosseininasab D, Shiraseb F, Noori S, Jamili S, Mazaheri-Eftekhar F, Dehghan M, da Silva A, Bressan J, Mirzaei K. The relationship between ultra-processed food intake and cardiometabolic risk factors in overweight and obese women: A cross-sectional study. Front Nutr. 2022 Aug 9;9:945591. doi: 10.3389/fnut.2022.945591. eCollection 2022.

  PMID: 36017229 BACKGROUND

• Elizabeth L, Machado P, Zinocker M, Baker P, Lawrence M. Ultra-Processed Foods and Health Outcomes: A Narrative Review. Nutrients. 2020 Jun 30;12(7):1955. doi: 10.3390/nu12071955.

  PMID: 32630022 BACKGROUND

• Juul F, Martinez-Steele E, Parekh N, Monteiro CA, Chang VW. Ultra-processed food consumption and excess weight among US adults. Br J Nutr. 2018 Jul;120(1):90-100. doi: 10.1017/S0007114518001046. Epub 2018 May 6.

  PMID: 29729673 BACKGROUND

• Monteiro CA, Cannon G, Levy RB, Moubarac JC, Louzada ML, Rauber F, Khandpur N, Cediel G, Neri D, Martinez-Steele E, Baraldi LG, Jaime PC. Ultra-processed foods: what they are and how to identify them. Public Health Nutr. 2019 Apr;22(5):936-941. doi: 10.1017/S1368980018003762. Epub 2019 Feb 12.

  PMID: 30744710 BACKGROUND

• Juul F, Vaidean G, Parekh N. Ultra-processed Foods and Cardiovascular Diseases: Potential Mechanisms of Action. Adv Nutr. 2021 Oct 1;12(5):1673-1680. doi: 10.1093/advances/nmab049.

  PMID: 33942057 BACKGROUND

• Juul F, Vaidean G, Lin Y, Deierlein AL, Parekh N. Ultra-Processed Foods and Incident Cardiovascular Disease in the Framingham Offspring Study. J Am Coll Cardiol. 2021 Mar 30;77(12):1520-1531. doi: 10.1016/j.jacc.2021.01.047.

  PMID: 33766258 BACKGROUND

• Ozkan I, Ozlu Karahan T, Seven Avuk H. Processed Food Consumption Based on the NOVA Classification Is Associated With Elevated Cardiometabolic Risk in Turkish Adults. Food Sci Nutr. 2025 Sep 26;13(10):e71014. doi: 10.1002/fsn3.71014. eCollection 2025 Oct.

  PMID: 41019184 DERIVED

Related Links

• Ministry of Health, General Directorate of Public Health. (2022). Türkiye Nutrition Guide (TUBER) 2022. Ministry of Health Publication No: 1031. Ankara: Ministry of Health.

MeSH Terms

Conditions

Heart Diseases; Cardiovascular Diseases; Nutrition Disorders; Obesity

Interventions

Observation

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Hande Seven Avuk, PhD

  Istanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Head of Nutrition and Dietetic Department

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 30, 2025
• Study Start: March 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)