Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversiti Teknologi Mara

About this trial

The goal of this clinical trial is to learn about the effects of time-restricted eating in patients with history of acute coronary syndrome. The main questions it aims to answer are: 1) Is 10-hr TRE safe and feasible for patients with ACS; 2)What are the impacts of 10-hr TRE on anthropometric measurements, cardiometabolic health and cardiovascular health compared to ad libitum eating in patients with ACS?. Participants will be asked to limit eating duration to 10 hours daily.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Time-restricted eating 10-hr

    Behavioral

    Time-restricted eating is a form of intermittent fasting. In this study, 10-hr TRE will be employed, where eating duration is limited to 10 hours. Participants are allowed to consume non-caloric beverages during fasting period.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Ad-libitum eating durationNo intervention 0 interventions
Group B: Time-restricted eating (TRE) durationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in weight

unit: kg

Time frame
4 weeks (pre- & post intervention)

Secondary outcomes

1

Change in lean body mass

unit : kg

Time frame
4 weeks (pre- & post intervention)
2

Change in fat mass

unit : kg

Time frame
4 weeks (pre- & post intervention)
3

Change in fasting glucose concentration

Glycaemic biomarker, unit: mmol/L

Time frame
4 weeks (pre- & post intervention)
4

Change in fasting insulin concentration

Glycaemic biomarker, unit:pmol/L

Time frame
4 weeks (pre- & post intervention)

Other outcomes

1

Rate of weekly compliance to intervention

Adherence to intervention, number of days complied to eating duration assigned/ 7 daysx100%

Time frame
4 weeks
2

Change in caloric intake

Dietary energy consumption, unit: kcal/day

Time frame
4 weeks (pre- & post intervention)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiti Teknologi Mara

Lead sponsor

Ministry of Higher Education, Malaysia

Collaborator