Cardiac DiseaseNCT06996262
Cardiometabolic Risk Factors and Processed Food
An observational study of Cardiac Disease and Cardiovascular Diseases, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease, Cardiovascular Diseases, Nutrition
- What is being tested?
- observational study
- How many people
- 236 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 Apr 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatients applying to the internal medicine polyclinic
Who may be able to join
- aged 18-65 years
- volunteers patients
Who cannot join
- people under 18 years of ages
- people over 65 years of ages
- pregnant and breastfeeding women
- individuals with active cancer or chronic illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between NOVA-Classified Processed Food Intake and Cardiometabolic Risk Factors in Türkiye
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.
Read more
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
- Being tested
- observational study
- Keywords
- processed food, cardiometabolic risk, obesity, Framingham risk score
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases, Nutrition Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
The questionnaire consisted of structured questions covering sociodemographic information, health status, dietary habits, and physical activity levels.
observational studyOther
Anthropometric measurements was taken.
observational studyOther
Biochemical analyses were measured was measured using routine methods.
observational studyOther
Blood pressure were measured was measured using routine methods.
| Study group | Role | What they receive |
|---|---|---|
| Observational Study Group | * Aged 18-65,
* Volunteers at the Zonguldak Atatürk State Hospital
* Outpatients applying to the internal medicine polyclinic Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: Baseline
Anthropometric Measurements - Height
Height (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Measured: Baseline
Body Mass Index
The body mass index (BMI) of the participants was calculated according to the body weight (kg) / height (m)2 formula.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline
Anthropometric Measurements - Waist/Hip Ratio
Waist/hip ratio was obtained by dividing waist circumference by hip circumference.
Measured: Baseline
Anthropometric Measurements - Waist/Height Ratio
Waist/height ratio was obtained by dividing waist circumference by height.
Measured: 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.
Measured: Baseline
Food Frequency Record
Food frequency records were taken to assess processed and ultra-processed food consumption according to the Nova classification.
Measured: Baseline
Secondary outcomes (2)
Physical Activity Levels
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.
Measured: Baseline
Physical Activity Levels Classification
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Mar 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 236 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Seven Avuk, Istanbul Bilgi University
- Investigators
- Hande Seven Avuk, PhD, Principal investigator, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996262
- Sponsor's protocol ID
- ULTRAHEARTTR
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34327504Hosseininasab 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.
PubMed 36017229Elizabeth 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.
PubMed 32630022Juul 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.
PubMed 29729673Monteiro 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.
PubMed 30744710Juul 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.
PubMed 33942057Juul 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.
PubMed 33766258Ozkan 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.
PubMed 41019184
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between NOVA-Classified Processed Food Intake and Cardiometabolic Risk Factors in Türkiye
- ClinicalTrials.gov ID
- NCT06996262
- Acronym / sponsor ID
- ULTRAHEARTTR
- Conditions
- Cardiac Disease, Cardiovascular Diseases, Nutrition, Nutritional Disease, Cardiometabolic Diseases, Cardiometabolic Risk Factors
- Keywords
- processed food, cardiometabolic risk, obesity, Framingham risk score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Study Group | – | Other: observational study* Aged 18-65, * Volunteers at the Zonguldak Atatürk State Hospital * Outpatients applying to the internal medicine polyclinic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients applying to the internal medicine polyclinic
Key inclusion criteria (2 listed)
- aged 18-65 years
- volunteers patients
Key exclusion criteria (4 listed)
- people under 18 years of ages
- people over 65 years of ages
- pregnant and breastfeeding women
- individuals with active cancer or chronic illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyThe questionnaire consisted of structured questions covering sociodemographic information, health status, dietary habits, and physical activity levels. | Other | Observational Study Group |
| observational studyAnthropometric measurements was taken. | Other | Observational Study Group |
| observational studyBiochemical analyses were measured was measured using routine methods. | Other | Observational Study Group |
| observational studyBlood pressure were measured was measured using routine methods. | Other | Observational Study Group |
Primary outcome
Biochemical Measurements - Fasting blood glucose
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.
Biochemical Measurement - Lipid Profile
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.
Biochemical Measurements - HbA1C
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.
Biochemical Measurements - Uric acid
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.
Blood Pressures
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.
Framingham Risk Score
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.
Framingham Risk Percentage
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. * 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)
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.
Anthropometric Measurements - Height
Time frame: Baseline
Height (cm) was measured with a stadiometer in the Frankfort plane, standing and with the head upright.
Body Mass Index
Time frame: Baseline
The body mass index (BMI) of the participants was calculated according to the body weight (kg) / height (m)2 formula.
Body Mass Index Classification
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.
Anthropometric Measurements - Waist circumference
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.
Anthropometric Measurements - Hip circumference
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).
Anthropometric Measurements - Waist/Hip Ratio
Time frame: Baseline
Waist/hip ratio was obtained by dividing waist circumference by hip circumference.
Anthropometric Measurements - Waist/Height Ratio
Time frame: Baseline
Waist/height ratio was obtained by dividing waist circumference by height.
Anthropometric Measurements - Neck Circumference
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.
Food Frequency Record
Time frame: Baseline
Food frequency records were taken to assess processed and ultra-processed food consumption according to the Nova classification.
2 secondary outcomes
Physical Activity Levels
Time frame: Baseline
Physical Activity Levels Classification
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Background: PubMed 34327504Tokgozoglu 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.
- Background: PubMed 36017229Hosseininasab 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.
- Background: PubMed 32630022Elizabeth 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.
- Background: PubMed 29729673Juul 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.
- Background: PubMed 30744710Monteiro 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.
- Background: PubMed 33942057Juul 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.
- Background: PubMed 33766258Juul 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.
- Derived from this study: PubMed 41019184Ozkan 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.
- Ministry of Health, General Directorate of Public Health. (2022). Türkiye Nutrition Guide (TUBER) 2022. Ministry of Health Publication No: 1031. Ankara: Ministry of Health.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hande Seven Avuk, PhD principal investigator
Istanbul Bilgi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease and Cardiovascular Diseases, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Measurements - Fasting blood glucose (time frame: Baseline). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06996262, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.