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/NCT05968378</url>
    </required_header>
    <id_info>
      <org_study_id>LS-E-22-105-Shannon-Roche</org_study_id>
      <nct_id>NCT05968378</nct_id>
    </id_info>
    <brief_title>Diet, Immunometabolism and Non-alcoholic Fatty Liver Disease</brief_title>
    <official_title>Immunometabolic Effects of Time Restricted Eating in Non-alcoholic Fatty Liver Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University College Dublin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>St. James's Hospital, Ireland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University College Dublin</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This study will assess the impact of 8-hour time restricted eating (8 hours of eating, 16&#xD;
        hours fasting) combined with a Mediterranean diet on metabolism and inflammation in adults&#xD;
        with non-alcoholic fatty liver disease (NAFLD).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Non-alcoholic fatty liver disease (NAFLD), defined as the accumulation of fat in the liver&#xD;
        that is not related to alcohol intake, is the number 1 global cause of chronic liver disease.&#xD;
        Excessive consumption of energy, saturated fat, and simple sugars is a key contributor to&#xD;
        hepatic lipid accumulation and obesity-induced metabolic inflammation, reflecting cross-talk&#xD;
        between immune and metabolic pathways. Moreover, dietary factors including saturated fatty&#xD;
        acids, cholesterol, and their derivatives, as well as gut-derived metabolites, can prime&#xD;
        innate immune cells to induce an exaggerated pro-inflammatory response upon re-exposure to&#xD;
        such stimuli and may contribute to chronic low grade inflammation.&#xD;
  &#xD;
        Dietary strategies focusing on replacing inflammatory dietary triggers with monounsaturated&#xD;
        fats, fiber and complex carbohydrates have been shown to improve metabolic dysfunction, but&#xD;
        how this relates to a rewiring of the innate immune system is less clear. Time-restricted&#xD;
        eating (TRE) is another dietary strategy which has been shown to elicit beneficial effects&#xD;
        that reduce the risk of chronic metabolic disease and consolidates eating to a 6-10 hour&#xD;
        period daily. Early TRE (eTRE), wherein eating occurs from morning to early afternoon, is&#xD;
        associated with greater cardiometabolic health benefits than eating late in the evening. This&#xD;
        includes improved insulin sensitivity, glucose tolerance and lipid metabolism, and reduced&#xD;
        inflammatory markers.&#xD;
  &#xD;
        This study will determine the impact of an 8-week intervention of 8-hour eTRE combined with&#xD;
        an anti-inflammatory Mediterranean diet on the metabolic and immune phenotype of individuals&#xD;
        with NAFLD, a population at high risk of progressive cardiometabolic decline and chronic&#xD;
        inflammation. By focusing on improving both nutrient quality and nutrient timing, a greater&#xD;
        understanding of the interaction between systemic metabolism and immune cell rewiring will be&#xD;
        gained.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">June 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in plasma inflammatory response to a high-fat meal: C-reactive protein (CRP)</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>Postprandial changes in CRP (mg/L) will be measured in response to a high-fat meal</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in plasma inflammatory response to a high-fat meal: Interleukin-6 (IL-6)</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>Postprandial changes in IL-6 (pg/mL) will be measured in response to a high-fat meal</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in plasma inflammatory response to a high-fat meal: Interleukin-1-beta (IL-1β)</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>Postprandial changes in IL-1β (pg/mL) will be measured in response to a high-fat meal</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in plasma inflammatory response to a high-fat meal: Tumor necrosis factor alpha (TNF-α)</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>Postprandial changes in (TNF-α) (pg/mL) will be measured in response to a high-fat meal</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in metabolic response to a high-fat meal: Glucose</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>Plasma glucose (mg/dL) response to a high-fat meal will be assessed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in metabolic response to a high-fat meal: Insulin</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>Plasma insulin (μU/mL) response to a high-fat meal will be assessed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in metabolic response to a high-fat meal: Glucagon</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>Plasma glucagon (pg/mL) response to a high-fat meal will be assessed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in metabolic response to a high-fat meal: Triglycerides</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>Plasma triglycerides (mg/dL) response to a high-fat meal will be assessed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in metabolic response to a high-fat meal: Non-esterified fatty acids (NEFA)</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>Plasma NEFA (mmol/L) response to a high-fat meal will be assessed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Innate immune function</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week change in innate immune function will be assessed ex-vivo using whole blood simulation assay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Innate immune training</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week change in innate immune function will be assessed in isolated monocytes stimulated with beta glucan and restimulated with lipopolysaccharide.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin resistance</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week change in insulin resistance using Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adipose tissue insulin resistance</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week change in adipose tissue insulin resistance using the adipose tissue insulin resistance index (Adipo-IR).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in intrahepatic triglyceride content</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>Liver elastography (FibroScan) will be used to determine change in liver fat after the 8-week intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in liver stiffness measurement</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>Liver elastography (FibroScan) will be used to determine change in liver stiffness after the 8-week intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HDL Proteome</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week change in the composition of the HDL proteome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body weight</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week change in body weight in kilograms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index (BMI)</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week change in BMI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body fat percentage</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8 week change in body fat percentage using bioelectrical impedance analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waist and hip circumferences</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week change in waist and hip circumference measured in centimeters using a body tape measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gut microbiome composition and function</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week functional changes in gut microbiome will be assessed by integrating 16S sequencing of fecal samples with fecal water metabolomics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dietary intake</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week change in dietary intake using a 3-day semi-weighed food diary.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity level (PAL)</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week change in PAL using the International Physical Activity Questionnaire - Short form (IPAQ-SF). This form has 7 questions about time spent doing physical activity(leisure time, work, domestic tasks, and travel) in the last 7 days. Activities are grouped according to vigorous or moderate intensity, and walking. Each intensity is assigned a metabolic equivalent (MET). The time spent at each intensity is used to estimate weekly physical activity using the associated METs. Minimum and maximum values are 0 and 154,224 METs. Classification as 'sufficiently active' requires ≥600 METs/week which may be achieved through a combination of intensities. Classification as 'highly active' requires: a) vigorous-intensity activity on ≥3 days achieving a minimum of ≥1500 METs/week OR b) ≥7 days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving ≥ 3000 METs/week. A physical activity level below these categories is undesirable.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mediterranean diet adherence</measure>
      <time_frame>To be assessed at baseline and post 8-week intervention</time_frame>
      <description>8-week change in Mediterranean diet adherence score using the PREDIMED 14-item Mediterranean Diet Assessment Tool. This questionnaire is used to assess adherence to the traditional Mediterranean Diet. Two of the 14 questions relate to the use of olive oil, a key component of the Mediterranean Diet, and 12 questions relate to the consumption of foods which characterize the Mediterranean Diet. Each item has a criteria which must be met to achieve 1 point e.g., at least 3 pieces of fruit daily. The minimum score is 0 and the maximum is 14, where a score of ≤ 5 indicates low adherence, 6-9 moderate adherence, and &gt; 9 high adherence.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Non-Alcoholic Fatty Liver Disease</condition>
    <condition>Liver Fat</condition>
    <condition>Obesity</condition>
    <condition>Inflammation</condition>
    <arm_group>
      <arm_group_label>Standard healthy eating advice</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects in this group will be counselled according to the Irish National Healthy Eating Guidelines.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>eTRE plus Mediterranean diet</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects in this group will be asked to restrict their eating to 8-hours daily (8am - 4pm) and to adhere to a Mediterranean style diet.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard healthy eating advice</intervention_name>
      <description>Subjects in this group will be provided with standard healthy eating advice according to the Irish National Healthy Eating Guidelines and Food Pyramid and will be asked to follow this advice for 8-weeks.</description>
      <arm_group_label>Standard healthy eating advice</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>eTRE plus Mediterranean diet</intervention_name>
      <description>Subjects in this group will be asked to consume all meals between 8am - 4pm and to adhere to a Mediterranean style diet daily for 8-weeks.</description>
      <arm_group_label>eTRE plus Mediterranean diet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males and females&#xD;
  &#xD;
            -  Age 18-65 years, from all ethnic groups, capable of providing informed consent to&#xD;
               participate&#xD;
  &#xD;
            -  Obesity (body mass index &gt;30kg/m^2) and of stable body weight (±3% for ≥3 months)&#xD;
  &#xD;
            -  Fasting blood glucose &lt;7.0 mmol/L and HbA1c &lt;6.5%.&#xD;
  &#xD;
            -  Liver fat &gt;10% (CAP score &gt;238 dB/m) and no fibrosis (liver stiffness score 2-7 kPa)&#xD;
               as assessed by liver elastography (FibroScan)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Impaired renal function&#xD;
  &#xD;
            -  Abnormal hematocrit&#xD;
  &#xD;
            -  History of cardiovascular events&#xD;
  &#xD;
            -  Uncontrolled hypertension&#xD;
  &#xD;
            -  Type 2 diabetes&#xD;
  &#xD;
            -  Medications or supplements known to affect glucose or lipid metabolism&#xD;
  &#xD;
            -  Active inflammatory, autoimmune, infectious, gastrointestinal, or malignant disease&#xD;
  &#xD;
            -  Uncontrolled neurological or psychiatric disease&#xD;
  &#xD;
            -  Iron deficiency anemia, (hemoglobin &lt; 12g/dl men, &lt; 11g/dl women)&#xD;
  &#xD;
            -  Fatty acid supplements and consumers of high doses of anti- antioxidant vitamins (A,&#xD;
               C, E, b-carotene)&#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_contact>
      <last_name>Helen M Roche, Professor</last_name>
      <phone>+353017164031</phone>
      <email>helen.roche@ucd.ie</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Christopher E Shannon, PhD</last_name>
      <email>christopher.shannon@ucd.ie</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University College Dublin</name>
        <address>
          <city>Dublin</city>
          <state>Leinster</state>
          <zip>D04 V1W8</zip>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Helen M Roche, Professor</last_name>
        <phone>+353 01 7164031</phone>
        <email>helen.roche@ucd.ie</email>
      </contact>
      <contact_backup>
        <last_name>Christopher E Shannon, PhD</last_name>
        <email>christopher.shannon@ucd.ie</email>
      </contact_backup>
      <investigator>
        <last_name>Helen M Roche, Professor</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Ireland</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Diseases</mesh_term>
      <mesh_term>Fatty Liver</mesh_term>
      <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <!-- 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/NCT05968378
  org study id: LS-E-22-105-Shannon-Roche
  nct id: NCT05968378
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study will assess the impact of 8-hour time restricted eating (8 hours of eating, 16
        hours fasting) combined with a Mediterranean diet on metabolism and inflammation in adults
        with non-alcoholic fatty liver disease (NAFLD).
  Non-alcoholic fatty liver disease (NAFLD), defined as the accumulation of fat in the liver
        that is not related to alcohol intake, is the number 1 global cause of chronic liver disease.
        Excessive consumption of energy, saturated fat, and simple sugars is a key contributor to
        hepatic lipid accumulation and obesity-induced metabolic inflammation, reflecting cross-talk
        between immune and metabolic pathways. Moreover, dietary factors including saturated fatty
        acids, cholesterol, and their derivatives, as well as gut-derived metabolites, can prime
        innate immune cells to induce an exaggerated pro-inflammatory response upon re-exposure to
        such stimuli and may contribute to chronic low grade inflammation.
  
        Dietary strategies focusing on replacing inflammatory dietary triggers with monounsaturated
        fats, fiber and complex carbohydrates have been shown to improve metabolic dysfunction, but
        how this relates to a rewiring of the innate immune system is less clear. Time-restricted
        eating (TRE) is another dietary strategy which has been shown to elicit beneficial effects
        that reduce the risk of chronic metabolic disease and consolidates eating to a 6-10 hour
        period daily. Early TRE (eTRE), wherein eating occurs from morning to early afternoon, is
        associated with greater cardiometabolic health benefits than eating late in the evening. This
        includes improved insulin sensitivity, glucose tolerance and lipid metabolism, and reduced
        inflammatory markers.
  
        This study will determine the impact of an 8-week intervention of 8-hour eTRE combined with
        an anti-inflammatory Mediterranean diet on the metabolic and immune phenotype of individuals
        with NAFLD, a population at high risk of progressive cardiometabolic decline and chronic
        inflammation. By focusing on improving both nutrient quality and nutrient timing, a greater
        understanding of the interaction between systemic metabolism and immune cell rewiring will be
        gained.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in plasma inflammatory response to a high-fat meal: C-reactive protein (CRP)
  time frame: To be assessed at baseline and post 8-week intervention
  description: Postprandial changes in CRP (mg/L) will be measured in response to a high-fat meal
  measure: Change in plasma inflammatory response to a high-fat meal: Interleukin-6 (IL-6)
  time frame: To be assessed at baseline and post 8-week intervention
  description: Postprandial changes in IL-6 (pg/mL) will be measured in response to a high-fat meal
  measure: Change in plasma inflammatory response to a high-fat meal: Interleukin-1-beta (IL-1β)
  time frame: To be assessed at baseline and post 8-week intervention
  description: Postprandial changes in IL-1β (pg/mL) will be measured in response to a high-fat meal
  measure: Change in plasma inflammatory response to a high-fat meal: Tumor necrosis factor alpha (TNF-α)
  time frame: To be assessed at baseline and post 8-week intervention
  description: Postprandial changes in (TNF-α) (pg/mL) will be measured in response to a high-fat meal
  measure: Change in metabolic response to a high-fat meal: Glucose
  time frame: To be assessed at baseline and post 8-week intervention
  description: Plasma glucose (mg/dL) response to a high-fat meal will be assessed
  measure: Change in metabolic response to a high-fat meal: Insulin
  time frame: To be assessed at baseline and post 8-week intervention
  description: Plasma insulin (μU/mL) response to a high-fat meal will be assessed
  measure: Change in metabolic response to a high-fat meal: Glucagon
  time frame: To be assessed at baseline and post 8-week intervention
  description: Plasma glucagon (pg/mL) response to a high-fat meal will be assessed
  measure: Change in metabolic response to a high-fat meal: Triglycerides
  time frame: To be assessed at baseline and post 8-week intervention
  description: Plasma triglycerides (mg/dL) response to a high-fat meal will be assessed
  measure: Change in metabolic response to a high-fat meal: Non-esterified fatty acids (NEFA)
  time frame: To be assessed at baseline and post 8-week intervention
  description: Plasma NEFA (mmol/L) response to a high-fat meal will be assessed
  measure: Innate immune function
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week change in innate immune function will be assessed ex-vivo using whole blood simulation assay.
  measure: Innate immune training
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week change in innate immune function will be assessed in isolated monocytes stimulated with beta glucan and restimulated with lipopolysaccharide.
  measure: Insulin resistance
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week change in insulin resistance using Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
  measure: Adipose tissue insulin resistance
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week change in adipose tissue insulin resistance using the adipose tissue insulin resistance index (Adipo-IR).
  measure: Change in intrahepatic triglyceride content
  time frame: To be assessed at baseline and post 8-week intervention
  description: Liver elastography (FibroScan) will be used to determine change in liver fat after the 8-week intervention.
  measure: Change in liver stiffness measurement
  time frame: To be assessed at baseline and post 8-week intervention
  description: Liver elastography (FibroScan) will be used to determine change in liver stiffness after the 8-week intervention.
  measure: HDL Proteome
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week change in the composition of the HDL proteome.
  measure: Body weight
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week change in body weight in kilograms
  measure: Body mass index (BMI)
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week change in BMI
  measure: Body fat percentage
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8 week change in body fat percentage using bioelectrical impedance analysis
  measure: Waist and hip circumferences
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week change in waist and hip circumference measured in centimeters using a body tape measure
  measure: Gut microbiome composition and function
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week functional changes in gut microbiome will be assessed by integrating 16S sequencing of fecal samples with fecal water metabolomics.
  measure: Dietary intake
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week change in dietary intake using a 3-day semi-weighed food diary.
  measure: Physical activity level (PAL)
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week change in PAL using the International Physical Activity Questionnaire - Short form (IPAQ-SF). This form has 7 questions about time spent doing physical activity(leisure time, work, domestic tasks, and travel) in the last 7 days. Activities are grouped according to vigorous or moderate intensity, and walking. Each intensity is assigned a metabolic equivalent (MET). The time spent at each intensity is used to estimate weekly physical activity using the associated METs. Minimum and maximum values are 0 and 154,224 METs. Classification as 'sufficiently active' requires ≥600 METs/week which may be achieved through a combination of intensities. Classification as 'highly active' requires: a) vigorous-intensity activity on ≥3 days achieving a minimum of ≥1500 METs/week OR b) ≥7 days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving ≥ 3000 METs/week. A physical activity level below these categories is undesirable.
  measure: Mediterranean diet adherence
  time frame: To be assessed at baseline and post 8-week intervention
  description: 8-week change in Mediterranean diet adherence score using the PREDIMED 14-item Mediterranean Diet Assessment Tool. This questionnaire is used to assess adherence to the traditional Mediterranean Diet. Two of the 14 questions relate to the use of olive oil, a key component of the Mediterranean Diet, and 12 questions relate to the consumption of foods which characterize the Mediterranean Diet. Each item has a criteria which must be met to achieve 1 point e.g., at least 3 pieces of fruit daily. The minimum score is 0 and the maximum is 14, where a score of ≤ 5 indicates low adherence, 6-9 moderate adherence, and > 9 high adherence.
  arm group label: Standard healthy eating advice
  arm group type: Active Comparator
  description: Subjects in this group will be counselled according to the Irish National Healthy Eating Guidelines.
  arm group label: eTRE plus Mediterranean diet
  arm group type: Experimental
  description: Subjects in this group will be asked to restrict their eating to 8-hours daily (8am - 4pm) and to adhere to a Mediterranean style diet.
  intervention type: Behavioral
  intervention name: Standard healthy eating advice
  description: Subjects in this group will be provided with standard healthy eating advice according to the Irish National Healthy Eating Guidelines and Food Pyramid and will be asked to follow this advice for 8-weeks.
  arm group label: Standard healthy eating advice
  intervention type: Behavioral
  intervention name: eTRE plus Mediterranean diet
  description: Subjects in this group will be asked to consume all meals between 8am - 4pm and to adhere to a Mediterranean style diet daily for 8-weeks.
  arm group label: eTRE plus Mediterranean diet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Helen M Roche, Professor
  phone: +353017164031
  email: helen.roche@ucd.ie
  last name: Christopher E Shannon, PhD
  email: christopher.shannon@ucd.ie
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Ireland
  responsible party type: Sponsor
  mesh term: Liver Diseases
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease
  mesh term: Inflammation