Effects of time-restricted eating on heart health

Impacts of Time-Restricted Eating on Weight, Cardiometabolic and Cardiovascular Health in Patients With Acute Coronary Syndrome

This study is testing if a 10-hour eating schedule can improve heart health in people who have had a heart problem compared to eating normally.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Universiti Teknologi Mara (Academic / other)
• Locations: 1 site (Kuala Selangor)
• Trial ID: NCT06007950 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of a 10-hour time-restricted eating (TRE) regimen on patients with a history of acute coronary syndrome (ACS). It aims to determine the safety and feasibility of this eating pattern while assessing its impact on anthropometric measurements, cardiometabolic health, and cardiovascular outcomes compared to unrestricted eating. The study employs a randomized controlled design, with participants assigned to either the TRE group or a control group for a four-week intervention period following a one-week baseline. The trial is conducted under the oversight of the Universiti Teknologi MARA Ethics Committee.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 with a history of acute coronary syndrome who are clinically stable.

Not a fit: Patients with severe obesity, unstable weight, or certain chronic conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel dietary approach to improve heart health and metabolic outcomes in patients with a history of acute coronary syndrome.

How similar studies have performed: While some studies have shown positive effects of time-restricted eating in various populations, research specifically targeting patients with heart disease is limited and this approach may be novel.

Eligibility criteria

Inclusion Criteria:

* Adult, 18- 65 years old.
* Had history of acute coronary syndrome (ACS)
* Clinically stable
* Self-reported eating window of at least 12 h per day.

Exclusion Criteria:

* Severe obesity (body mass index ≥40 kg m-2).
* Unstable weight in the past three months (gain or lose more than 4 kg of weight).
* Unstable cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system disease that may compromise study validity.
* Any medications or supplements known to change sleep, circadian rhythms, or metabolism.
* Pregnant or lactating women.
* Perform overnight shift work more than one day/week on average.
* Regularly fasted for more than 15 hours/day or having completed twelve 24-hr fasts within the past three months).
* Active use of tobacco or illicit drug or history of treatment for alcohol abuse.
* Type I diabetes or diabetic, treated with insulin.
* Use of anti-obesity drugs or other drugs affecting body weight.
* Currently enrolled in weight loss or management programme, including surgical intervention.
* Severe kidney failure (glomerular filtration rate (GFR) \<30 mL/min).
* Eating disorder or current diagnosis of uncontrolled psychiatric illness, which may impair study involvement.
* Malignancy undergoing active treatment.
* Had gastrointestinal surgery or impaired nutrient absorption.
* Travelled more than two time zones away two months prior to enrolling in the trial or will travel more than two time zones away during the study period.
* Concurrent participation in other interventional studies

Where this trial is running

Kuala Selangor

• Pusat Perkhidmatan Klinikal (CTC) UiTM — Kuala Selangor, Malaysia (Recruiting)

Study contacts

• Principal investigator: Mazuin Kamarul Zaman, MMed Sc — Universiti Teknologi Mara
• Study coordinator: Mazuin Kamarul Zaman, MMed Sc

Conditions Myocardial Infarction; coronary heart disease; time-restricted eating; intermittent fasting