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Not yet recruitingNCT07870109PVTUpdated Oct 13, 2026

Premature Ventricular Complex and Diet Inflamatuar Index

An observational study in Premature Ventricular Complexes, Diet Quality and Biochemical Markers, sponsored by Izmir Democracy University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Izmir Democracy University · Observational

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The aim of this study is to evaluate differences in energy, macro- and micronutrient intakes, dietary characteristics, quality of life, and biochemical parameters between individuals with and without premature ventricular complexes. The study will include a total of 100 adults who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital, comprising 50 individuals with premature ventricular complexes and 50 healthy individuals. Participants will be instructed to discontinue caffeine-containing beverages, stimulants, and medications that may affect cardiac rhythm for 72 hours prior to Holter monitoring. The diagnosis of premature ventricular complexes will be established by a specialist cardiologist. Dietary intake will be assessed using three non-consecutive 24-hour dietary recalls, including two weekdays and one weekend day. Dietary intake data will be collected by the researcher through face-to-face interviews and recorded on the study questionnaire. The Dietary Inflammatory Index (DII) and Healthy Eating Index will be calculated based on the participants' three-day dietary intake data. No additional blood samples or biochemical tests will be requested specifically for the purposes of this study. Instead, the participants' most recent biochemical parameters obtained as part of routine clinical care will be retrieved from their medical records. These parameters will include fasting blood glucose (mg/dL), glycated hemoglobin (HbA1c, %), total cholesterol (mg/dL), high-density lipoprotein cholesterol (HDL-C, mg/dL), low-density lipoprotein cholesterol (LDL-C, mg/dL), triglycerides (mg/dL), vitamin D, and other routinely assessed biochemical parameters. The results will be interpreted according to the reference ranges used by Buca Seyfi Demirsoy Training and Research Hospital. Participants' quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).

Read the detailed description

Although premature ventricular contractions are among the most common types of arrhythmia in patients both with and without structural heart disease, they may lead to long-term left ventricular dysfunction in patients with structurally normal hearts. An increased frequency of premature ventricular complexes (PVCs) may be associated with mental and physical stress, lifestyle-related factors, as well as cardiovascular risk factors such as hypertension, dyslipidemia, diabetes mellitus, and coronary artery disease. Frequent PVCs may lead to tachycardiomyopathy and, consequently, increased morbidity and mortality. The aim of this study is to evaluate differences in energy, macro- and micronutrient intakes, dietary characteristics, quality of life, and biochemical parameters between individuals with and without premature ventricular complexes. The study will include a total of 100 adults who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital, comprising 50 individuals with premature ventricular complexes and 50 healthy individuals. Participants will be instructed to discontinue caffeine-containing beverages, stimulants, and medications that may affect cardiac rhythm for 72 hours prior to Holter monitoring. The diagnosis of premature ventricular complexes will be established by a specialist cardiologist. Dietary intake will be assessed using three non-consecutive 24-hour dietary recalls, including two weekdays and one weekend day. Dietary intake data will be collected by the researcher through face-to-face interviews and recorded on the study questionnaire. The Dietary Inflammatory Index (DII) and Healthy Eating Index will be calculated based on the participants' three-day dietary intake data. No additional blood samples or biochemical tests will be requested specifically for the purposes of this study. Instead, the participants' most recent biochemical parameters obtained as part of routine clinical care will be retrieved from their medical records. These parameters will include fasting blood glucose (mg/dL), glycated hemoglobin (HbA1c, %), total cholesterol (mg/dL), high-density lipoprotein cholesterol (HDL-C, mg/dL), low-density lipoprotein cholesterol (LDL-C, mg/dL), triglycerides (mg/dL), vitamin D, and other routinely assessed biochemical parameters. The results will be interpreted according to the reference ranges used by Buca Seyfi Demirsoy Training and Research Hospital. Participants' quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).

02

Conditions studied

  • Premature Ventricular Complexes
  • Diet Quality
  • Biochemical Markers
  • Life Quality

Keywords

  • Premature Ventricular Complex
  • Diet Inflammatory Index
  • Life Quality
  • Blood Parameters
03

In context

Ventricular Premature Complexes

96 studies on the registry are indexed under Ventricular Premature Complexes; 29 are open to participants now.

This study's planned enrollment of 100 is below the median of 113 across 36 observational studies indexed under Ventricular Premature Complexes.

Browse Ventricular Premature Complexes studies →

Lead sponsor

Izmir Democracy University is the lead sponsor of 76 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study will include 50 individuals with premature ventricular complexes (PVCs) and 50 healthy adults who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital. Participants will be asked to discontinue caffeine-containing beverages, stimulants, and medications that may affect cardiac rhythm for 72 hours prior to Holter monitoring. The diagnosis of premature ventricular complexes will be established by a specialist cardiologist.

Eligibility criteria

Inclusion Criteria:

Inclusion criteria for individuals with premature ventricular complexes (PVCs):

  • Being between 18 and 80 years of age.
  • Having >10,000 PVCs/day, as determined by 24-hour Holter monitoring.

Inclusion criteria for healthy individuals:

  • Being between 18 and 80 years of age.
  • Having \<10,000 PVCs/day, as determined by 24-hour Holter monitoring.

Exclusion Criteria:

Exclusion criteria for individuals with premature ventricular complexes (PVC):

  • Having an active infection,
  • Having tachycardia due to secondary causes,
  • Having congestive heart failure (including PVC-induced tachycardiomyopathy),
  • Having symptomatic congenital heart disease,
  • Having symptomatic valvular heart disease,
  • Having diagnosed coronary artery disease,
  • Having a diagnosed psychiatric disorder,
  • Having an eating disorder such as anorexia nervosa or bulimia nervosa.

Exclusion criteria for healthy individuals:

  • Being \<18 or >80 years of age,
  • Having an active infection,
  • Having tachycardia due to secondary causes,
  • Having congestive heart failure (including PVC-induced tachycardiomyopathy),
  • Having symptomatic congenital heart disease,
  • Having symptomatic valvular heart disease,
  • Having diagnosed coronary artery disease,
  • Having a diagnosed psychiatric disorder,
  • Having an eating disorder such as anorexia nervosa or bulimia nervosa.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Patients of Premature Ventricular Complex

    The study will include 50 individuals with premature ventricular complexes who present to the Cardiology Outpatient Clinic of Buca Seyfi Demirsoy Training and Research Hospital.

06

What researchers measure

Primary outcomes

  1. Diet Inflammatory Index

    The Dietary Inflammatory Index will be calculated for patients with premature ventricular complexes

    Time frame: From enrollment to the end of treatment at 2 years

Secondary outcomes

  1. Diet Quality

    Diet quality will be assessed using the Diet Quality Index-International (DQI-I) scoring system

    Time frame: From enrollment to the end of treatment at 2 years

  2. Food Variety

    Participants' dietary variety will be determined using 3-day dietary records

    Time frame: From enrollment to the end of treatment at 2 years

  3. Glucose

    Serum glucose will be obtained from the participants' routine blood parameters.

    Time frame: From enrollment to the end of treatment at 2 years

  4. Hemoglobin A1c

    The data will be obtained from the participants' routine blood test results.

    Time frame: From enrollment to the end of treatment at 2 years

  5. Total Cholesterol

    The data will be obtained from the participants' routine blood test results.

    Time frame: From enrollment to the end of treatment at 2 years

  6. High Density Lipoprotein

    The data will be obtained from the participants' routine blood test results.

    Time frame: From enrollment to the end of treatment at 2 years

  7. Low Density Lipoprotein

    The data will be obtained from the participants' routine blood test results.

    Time frame: From enrollment to the end of treatment at 2 years

  8. Trygliseride

    The data will be obtained from the participants' routine blood test results.

    Time frame: From enrollment to the end of treatment at 2 years

  9. Vitamin D

    The data will be obtained from the participants' routine blood test results.

    Time frame: From enrollment to the end of treatment at 2 years

  10. Life Quality

    The Short Form-36 Health Survey will be used to assess the participants' quality of life.

    Time frame: From enrollment to the end of treatment at 2 years

07

Study locations

1 site
  • Buca Seyfi Demirsoy Training and Research Hospital
    Izmir, 35310, Turkey (Türkiye)
08

References and documents

Publications

  • Shivappa N, Steck SE, Hurley TG, Hussey JR, Hebert JR. Designing and developing a literature-derived, population-based dietary inflammatory index. Public Health Nutr. 2014 Aug;17(8):1689-96. doi: 10.1017/S1368980013002115. Epub 2013 Aug 14. PubMed 23941862 ↗
  • Geelen A, Brouwer IA, Schouten EG, Maan AC, Katan MB, Zock PL. Effects of n-3 fatty acids from fish on premature ventricular complexes and heart rate in humans. Am J Clin Nutr. 2005 Feb;81(2):416-20. doi: 10.1093/ajcn.81.2.416. PubMed 15699229 ↗
  • Kuyumcu, M. S., & Kuyumcu, A. (2020). Mediterranean diet effects on ventricular premature complexes. Annals of Medical Research, 27(1), 79.

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared to protect participant confidentiality and ensure compliance with data privacy requirements.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 13, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Nov 15, 2027
CompletionEst.
Nov 15, 2027
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07870109
Lead sponsor
Izmir Democracy University
Responsible party
Kerim Kaan Göküstün (Asistant Professor, Izmir Democracy University) — Principal investigator
First posted
Oct 13, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Nov 15, 2027 (estimated)
Completion
Nov 15, 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Kerim K GÖKÜSTÜN, PhD
Contact
kerimkaangokustun@hotmail.com
05058699031
Kerim K GÖKÜSTÜN, PhD
principal investigator · Izmir Democracy University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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