NCT07427199

Brief Summary

This study is designed to investigate the effect of a nutrition program supported by digital content on heart function in patients who have experienced a heart attack with ST-elevation. Participants will receive personalized dietary guidance and digital support materials for three months. The main goal is to determine whether this digital support materials can improve heart pumping function (measured by left ventricular ejection fraction). Participation involves following the dietary program and undergoing heart function measurements at the beginning, after one months and after three months.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Dec 2025Dec 2026

Study Start

First participant enrolled

December 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 23, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

February 16, 2026

Last Update Submit

February 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Left Ventricular Ejection Fraction (LVEF)

    Left ventricular ejection fraction will be measured using echocardiography at baseline, 1 month, and 3 months to evaluate the effect of digital content-supported medical nutrition therapy.

    Baseline, 1 month, 3 months

Study Arms (2)

Standard Dietary Care / Control

NO INTERVENTION

Participants in this group receive standard dietary care as routinely provided to patients after ST-elevation myocardial infarction, without additional digital content support. Heart function (LVEF) will be measured at baseline, 1 month, and 3 months.

Digital Content-Supported Nutrition Therapy

EXPERIMENTAL

Participants in this group receive a personalized medical nutrition therapy program supported by digital content, including educational materials, meal planning guides, and remote support. The program lasts 3 months, with follow-up visits at baseline, 1 month, and 3 months. Heart function (LVEF) will be measured at each time point.

Behavioral: Digital Content-Supported Medical Nutrition Therapy

Interventions

Participants receive a personalized medical nutrition therapy program supported by digital content. The program includes educational materials, meal planning guides, and remote support. The intervention lasts 3 months, with follow-up visits at baseline, 1 month, and 3 months. Heart function (LVEF) will be measured at each time point.

Digital Content-Supported Nutrition Therapy

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 19-65 who have fully completed the voluntary consent form
  • Being of normal weight (BMI 18.5-24.9 kg/m²) or obese (30-34.99 kg/m²)
  • Having suffered a heart attack with ST elevation (STEMI)
  • To be enrolled in the study within the first 72 hours after hospital admission
  • To be willing to participate in a follow-up period of at least 3 months

You may not qualify if:

  • Those who did not sign the voluntary consent form
  • Individuals aged over 65
  • Weight loss exceeding 5% in the last 3 months
  • Those with malignancy, chronic renal failure or severe systemic disease
  • Patients unable to complete the questionnaires due to severe cognitive impairment
  • Those who have previously received nutrition education or eating awareness training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs Üniversitesi Tıp Fakültesi Hastanesi

Samsun, Atakum, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Ziya Erokay Metin, Doç.Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Echocardiography assessments are performed by a cardiologist blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned in a parallel design to either the intervention group receiving digital content-supported medical nutrition therapy or the control group receiving standard dietary care. Heart function (LVEF) will be measured at baseline, at 1 month, and at 3 months of follow-up.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 23, 2026

Study Start

December 30, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations