xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06007950</url>
    </required_header>
    <id_info>
      <org_study_id>TRES2301</org_study_id>
      <nct_id>NCT06007950</nct_id>
    </id_info>
    <brief_title>Time-restricted Eating Study (TRES): Impacts on Anthropometric, Cardiometabolic and Cardiovascular Health</brief_title>
    <acronym>TRES</acronym>
    <official_title>Impacts of Time-Restricted Eating on Weight, Cardiometabolic and Cardiovascular Health in Patients With Acute Coronary Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universiti Teknologi Mara</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ministry of Higher Education Malaysia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universiti Teknologi Mara</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn about the effects of time-restricted eating in&#xD;
        patients with history of acute coronary syndrome. The main questions it aims to answer are:&#xD;
        1) Is 10-hr TRE safe and feasible for patients with ACS; 2)What are the impacts of 10-hr TRE&#xD;
        on anthropometric measurements, cardiometabolic health and cardiovascular health compared to&#xD;
        ad libitum eating in patients with ACS?. Participants will be asked to limit eating duration&#xD;
        to 10 hours daily.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Justification: The effects of TRE on humans varies results, with some showing improvements in&#xD;
        weight loss, insulin sensitivity, and cardiovascular markers, while others exhibiting no&#xD;
        significant changes. TRE studies on metabolically altered individuals especially patients&#xD;
        with heart diseases are limited.&#xD;
  &#xD;
        Written approval of the study has been obtained from the Universiti Teknologi MARA Ethics&#xD;
        Committee before commencement of this study.&#xD;
  &#xD;
        The TRES study utilizes an investigator-led, pragmatic, parallel, randomized, single-blinded&#xD;
        clinical trial design to evaluate the safety, feasibility, and effectiveness of a 10-hour&#xD;
        time-restricted eating (TRE) intervention compared to unrestricted eating in patients&#xD;
        diagnosed with acute coronary syndrome. The study aims to assess the impact of TRE on&#xD;
        anthropometric measurements, as well as cardiometabolic and cardiovascular health outcomes.&#xD;
        The duration of the randomized controlled trial (RCT) spans a period of five weeks. The trial&#xD;
        consisted of a baseline period of one week, which was then followed by a four-week&#xD;
        intervention phase. The participants will be assigned randomly to either the TRE&#xD;
        (Time-Restricted Eating) group or the control group, which involves ad libitum eating. They&#xD;
        will be instructed to adhere to their allotted eating duration during the four-week&#xD;
        intervention period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in weight</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>unit: kg</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in lean body mass</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>unit : kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fat mass</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>unit : kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fasting glucose concentration</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Glycaemic biomarker, unit: mmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fasting insulin concentration</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Glycaemic biomarker, unit:pmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in total cholesterol concentration</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Lipid metabolism biomarker, unit: mmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in high-density lipoprotein concentration</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Lipid metabolism biomarker, unit: mmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in low-density lipoprotein concentration</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Lipid metabolism biomarker, unit: mmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in triglycerides concentration</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Lipid metabolism biomarker, unit: mmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in C-reactive protein concentration</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Inflammatory biomarkers, unit: mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Malondialdehyde (MDA) level</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Oxidative stress Lipid peroxidation, unit:μmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in flow-mediated dilatation,</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Endothelial function, unit:%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Brachial-ankle pulse wave velocity</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>arterial stiffness, unit:m/s</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in perceived appetite</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Visual analog scale (VAS), linear scale in 100mm (not hungry at all-extremely hungry)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse event monitoring</measure>
      <time_frame>4 weeks</time_frame>
      <description>Report of incidence of adverse events for safety monitoring</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Hemoglobin level</measure>
      <time_frame>4 weeks</time_frame>
      <description>Safety monitoring, unit: g/dl</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sleep quality</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Pittsburgh Sleep Quality Index (PSQI) scale, A higher score indicates a worse sleep quality. PSQI score &gt;5= poor sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in physical activity</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Short version of the International Physical Activity Questionnaire (IPAQ), unit: metabolic equivalent (MET)-minutes</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Rate of weekly compliance to intervention</measure>
      <time_frame>4 weeks</time_frame>
      <description>Adherence to intervention, number of days complied to eating duration assigned/ 7 daysx100%</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in caloric intake</measure>
      <time_frame>4 weeks (pre- &amp; post intervention)</time_frame>
      <description>Dietary energy consumption, unit: kcal/day</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Myocardial Infarction</condition>
    <arm_group>
      <arm_group_label>Ad-libitum eating duration</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>24 patients will be randomly assigned to the control group. Participants will be asked to continue usual eating duration. Participants will receive the standard care and heart-healthy nutrition education.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Time-restricted eating (TRE) duration</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>24 patients will be randomly assigned to the intervention group. Participants in this arm will be asked to limit the number of hours they eat in a day to 10 hours in addition to receiving the standard of care health and heart-healthy nutrition education.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Time-restricted eating 10-hr</intervention_name>
      <description>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.</description>
      <arm_group_label>Time-restricted eating (TRE) duration</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult, 18- 65 years old.&#xD;
  &#xD;
            -  Had history of acute coronary syndrome (ACS)&#xD;
  &#xD;
            -  Clinically stable&#xD;
  &#xD;
            -  Self-reported eating window of at least 12 h per day.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe obesity (body mass index ≥40 kg m-2).&#xD;
  &#xD;
            -  Unstable weight in the past three months (gain or lose more than 4 kg of weight).&#xD;
  &#xD;
            -  Unstable cardiovascular, renal, cardiac, liver, lung, adrenal, or nervous system&#xD;
               disease that may compromise study validity.&#xD;
  &#xD;
            -  Any medications or supplements known to change sleep, circadian rhythms, or&#xD;
               metabolism.&#xD;
  &#xD;
            -  Pregnant or lactating women.&#xD;
  &#xD;
            -  Perform overnight shift work more than one day/week on average.&#xD;
  &#xD;
            -  Regularly fasted for more than 15 hours/day or having completed twelve 24-hr fasts&#xD;
               within the past three months).&#xD;
  &#xD;
            -  Active use of tobacco or illicit drug or history of treatment for alcohol abuse.&#xD;
  &#xD;
            -  Type I diabetes or diabetic, treated with insulin.&#xD;
  &#xD;
            -  Use of anti-obesity drugs or other drugs affecting body weight.&#xD;
  &#xD;
            -  Currently enrolled in weight loss or management programme, including surgical&#xD;
               intervention.&#xD;
  &#xD;
            -  Severe kidney failure (glomerular filtration rate (GFR) &lt;30 mL/min).&#xD;
  &#xD;
            -  Eating disorder or current diagnosis of uncontrolled psychiatric illness, which may&#xD;
               impair study involvement.&#xD;
  &#xD;
            -  Malignancy undergoing active treatment.&#xD;
  &#xD;
            -  Had gastrointestinal surgery or impaired nutrient absorption.&#xD;
  &#xD;
            -  Travelled more than two time zones away two months prior to enrolling in the trial or&#xD;
               will travel more than two time zones away during the study period.&#xD;
  &#xD;
            -  Concurrent participation in other interventional studies&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mazuin Kamarul Zaman, MMed Sc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universiti Teknologi Mara</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mazuin Kamarul Zaman, MMed Sc</last_name>
      <phone>+60332564397</phone>
      <email>mazuin0233@uitm.edu.my</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nur Islami Mohd Fahmi Teng, PhD</last_name>
      <phone>60332584540</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Pusat Perkhidmatan Klinikal (CTC) UiTM</name>
        <address>
          <city>Kuala Selangor</city>
          <country>Malaysia</country>
        </address>
      </facility>
      <contact>
        <last_name>Sazzli Shahlan Kasim, MBBCh</last_name>
        <phone>+60361265000</phone>
      </contact>
      <investigator>
        <last_name>Nur Islami Mohd Fahmi Teng, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Norsham Juliana, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Malaysia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universiti Teknologi Mara</investigator_affiliation>
      <investigator_full_name>MAZUIN KAMARUL ZAMAN</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>coronary heart disease</keyword>
    <keyword>time-restricted eating</keyword>
    <keyword>intermittent fasting</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myocardial Infarction</mesh_term>
      <mesh_term>Infarction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06007950
  org study id: TRES2301
  nct id: NCT06007950
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  Justification: The effects of TRE on humans varies results, with some showing improvements in
        weight loss, insulin sensitivity, and cardiovascular markers, while others exhibiting no
        significant changes. TRE studies on metabolically altered individuals especially patients
        with heart diseases are limited.
  
        Written approval of the study has been obtained from the Universiti Teknologi MARA Ethics
        Committee before commencement of this study.
  
        The TRES study utilizes an investigator-led, pragmatic, parallel, randomized, single-blinded
        clinical trial design to evaluate the safety, feasibility, and effectiveness of a 10-hour
        time-restricted eating (TRE) intervention compared to unrestricted eating in patients
        diagnosed with acute coronary syndrome. The study aims to assess the impact of TRE on
        anthropometric measurements, as well as cardiometabolic and cardiovascular health outcomes.
        The duration of the randomized controlled trial (RCT) spans a period of five weeks. The trial
        consisted of a baseline period of one week, which was then followed by a four-week
        intervention phase. The participants will be assigned randomly to either the TRE
        (Time-Restricted Eating) group or the control group, which involves ad libitum eating. They
        will be instructed to adhere to their allotted eating duration during the four-week
        intervention period.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Care Provider, Outcomes Assessor)
  measure: Change in weight
  time frame: 4 weeks (pre- & post intervention)
  description: unit: kg
  measure: Change in lean body mass
  time frame: 4 weeks (pre- & post intervention)
  description: unit : kg
  measure: Change in fat mass
  time frame: 4 weeks (pre- & post intervention)
  description: unit : kg
  measure: Change in fasting glucose concentration
  time frame: 4 weeks (pre- & post intervention)
  description: Glycaemic biomarker, unit: mmol/L
  measure: Change in fasting insulin concentration
  time frame: 4 weeks (pre- & post intervention)
  description: Glycaemic biomarker, unit:pmol/L
  measure: Change in total cholesterol concentration
  time frame: 4 weeks (pre- & post intervention)
  description: Lipid metabolism biomarker, unit: mmol/L
  measure: Change in high-density lipoprotein concentration
  time frame: 4 weeks (pre- & post intervention)
  description: Lipid metabolism biomarker, unit: mmol/L
  measure: Change in low-density lipoprotein concentration
  time frame: 4 weeks (pre- & post intervention)
  description: Lipid metabolism biomarker, unit: mmol/L
  measure: Change in triglycerides concentration
  time frame: 4 weeks (pre- & post intervention)
  description: Lipid metabolism biomarker, unit: mmol/L
  measure: Change in C-reactive protein concentration
  time frame: 4 weeks (pre- & post intervention)
  description: Inflammatory biomarkers, unit: mg/dL
  measure: Change in Malondialdehyde (MDA) level
  time frame: 4 weeks (pre- & post intervention)
  description: Oxidative stress Lipid peroxidation, unit:μmol/L
  measure: Change in flow-mediated dilatation,
  time frame: 4 weeks (pre- & post intervention)
  description: Endothelial function, unit:%
  measure: Change in Brachial-ankle pulse wave velocity
  time frame: 4 weeks (pre- & post intervention)
  description: arterial stiffness, unit:m/s
  measure: Change in perceived appetite
  time frame: 4 weeks (pre- & post intervention)
  description: Visual analog scale (VAS), linear scale in 100mm (not hungry at all-extremely hungry)
  measure: Adverse event monitoring
  time frame: 4 weeks
  description: Report of incidence of adverse events for safety monitoring
  measure: Change in Hemoglobin level
  time frame: 4 weeks
  description: Safety monitoring, unit: g/dl
  measure: Change in sleep quality
  time frame: 4 weeks (pre- & post intervention)
  description: Pittsburgh Sleep Quality Index (PSQI) scale, A higher score indicates a worse sleep quality. PSQI score >5= poor sleep.
  measure: Change in physical activity
  time frame: 4 weeks (pre- & post intervention)
  description: Short version of the International Physical Activity Questionnaire (IPAQ), unit: metabolic equivalent (MET)-minutes
  measure: Rate of weekly compliance to intervention
  time frame: 4 weeks
  description: Adherence to intervention, number of days complied to eating duration assigned/ 7 daysx100%
  measure: Change in caloric intake
  time frame: 4 weeks (pre- & post intervention)
  description: Dietary energy consumption, unit: kcal/day
  arm group label: Ad-libitum eating duration
  arm group type: No Intervention
  description: 24 patients will be randomly assigned to the control group. Participants will be asked to continue usual eating duration. Participants will receive the standard care and heart-healthy nutrition education.
  arm group label: Time-restricted eating (TRE) duration
  arm group type: Experimental
  description: 24 patients will be randomly assigned to the intervention group. Participants in this arm will be asked to limit the number of hours they eat in a day to 10 hours in addition to receiving the standard of care health and heart-healthy nutrition education.
  intervention type: Behavioral
  intervention name: Time-restricted eating 10-hr
  description: 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.
  arm group label: Time-restricted eating (TRE) duration
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Mazuin Kamarul Zaman, MMed Sc
  role: Principal Investigator
  affiliation: Universiti Teknologi Mara
  last name: Mazuin Kamarul Zaman, MMed Sc
  phone: +60332564397
  email: mazuin0233@uitm.edu.my
  last name: Nur Islami Mohd Fahmi Teng, PhD
  phone: 60332584540
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: Malaysia
  responsible party type: Principal Investigator
  investigator affiliation: Universiti Teknologi Mara
  investigator full name: MAZUIN KAMARUL ZAMAN
  investigator title: Principal Investigator
  mesh term: Myocardial Infarction
  mesh term: Infarction
  sharing ipd: No