Clinical trial NCT06996262: Cardiometabolic Risk Factors and Processed Food
Official title: The Relationship Between NOVA-Classified Processed Food Intake and Cardiometabolic Risk Factors in Türkiye
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Cardiovascular Diseases
Nutrition
Nutritional Disease
Cardiometabolic Diseases
Cardiometabolic Risk Factors
Keywords: processed food
cardiometabolic risk
obesity
Framingham risk score
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients applying to the internal medicine polyclinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: Biochemical Measurements - Fasting blood glucose
timeFrame: Baseline
measure: Biochemical Measurement - Lipid Profile
timeFrame: Baseline
measure: Biochemical Measurements - HbA1C
timeFrame: Baseline
measure: Biochemical Measurements - Uric acid
timeFrame: Baseline
measure: Blood Pressures
timeFrame: Baseline
measure: Framingham Risk Score
timeFrame: Baseline
measure: Framingham Risk Percentage
timeFrame: Baseline
measure: Anthropometric Measurements - Body weight (kg)
timeFrame: Baseline
measure: Anthropometric Measurements - Height
timeFrame: Baseline
measure: Body Mass Index
timeFrame: Baseline
measure: Body Mass Index Classification
timeFrame: Baseline
measure: Anthropometric Measurements - Waist circumference
timeFrame: Baseline
measure: Anthropometric Measurements - Hip circumference
timeFrame: Baseline
measure: Anthropometric Measurements - Waist/Hip Ratio
timeFrame: Baseline
measure: Anthropometric Measurements - Waist/Height Ratio
timeFrame: Baseline
measure: Anthropometric Measurements - Neck Circumference
timeFrame: Baseline
measure: Food Frequency Record
timeFrame: Baseline
Secondary outcomes:
measure: Physical Activity Levels
timeFrame: Baseline
measure: Physical Activity Levels Classification
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Bilgi University
Study officials:
affiliation: Istanbul Bilgi University
name: Hande Seven Avuk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.