Premature Ventricular Complex and Diet Inflamatuar Index

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorIzmir Democracy University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Being between 18 and 80 years of age.

Having >10,000 PVCs/day, as determined by 24-hour Holter monitoring.

Being between 18 and 80 years of age.

Having <10,000 PVCs/day, as determined by 24-hour Holter monitoring.

Disqualifiers

Having an active infection,

Having tachycardia due to secondary causes,

Having congestive heart failure (including PVC-induced tachycardiomyopathy),

Having symptomatic congenital heart disease,

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Patients of Premature Ventricular Complex

Trial outcomes

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

Other outcomes

Sponsors and contacts

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