<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/NCT03278236</url>
  </required_header>
  <id_info>
    <org_study_id>HREC/17/RAH/307</org_study_id>
    <nct_id>NCT03278236</nct_id>
  </id_info>
  <brief_title>Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?</brief_title>
  <acronym>RESHAPE2</acronym>
  <official_title>Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Adelaide</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Salk Institute for Biological Studies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Adelaide</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>
      Obesity is a serious medical condition, the adverse consequences of which include increased&#xD;
      risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic&#xD;
      cost of obesity was placed at $58 billion dollars in Australia in 2008 [1]. Studies in mice&#xD;
      and non-human primates have shown that moderate caloric restriction (CR) increases lifespan&#xD;
      and reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes [2]. Reduced&#xD;
      risk of chronic diseases is also observed in humans following CR [3]. However, daily CR is&#xD;
      difficult to maintain long term, since the body defends against weight loss by inducing&#xD;
      &quot;metabolic adaptation&quot;[3] and altering the hormonal appetite response [4]. An emerging number&#xD;
      of studies are examining the effects of limiting food intake to prescribed time periods per&#xD;
      day, or every other day. Time restricted feeding (TRF) describes a dieting approach where&#xD;
      food is available ad libitum, however only for a limited period of time (i.e. 3-12 hours).&#xD;
&#xD;
      This pilot study will examine the effects of restricting daily food intake to within a 10&#xD;
      hour period on glycaemic control, body weight and biomarkers of metabolic health for 6-weeks.&#xD;
      This study will build on the existing knowledge base in humans as to whether meal timing,&#xD;
      rather than caloric restriction per se, is important to provide the stimulus required to&#xD;
      improve metabolic health and reduce risk of chronic disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The timing of meals distributed across the wake cycle may play a role in body weight&#xD;
      regulation and metabolic health. In rodents, providing an 12 h feeding opportunity during the&#xD;
      active phase abrogated the metabolic consequences of a high fat diet, including maintaining&#xD;
      leaner body weight and normal glucose homeostasis [5]. In diet-induced obese rodents,&#xD;
      switching to a TRF protocol normalised the metabolic milieu by reducing hyperinsulinemia,&#xD;
      hepatic steatosis, and inflammation [6]. Interestingly, when lean animals were switched to a&#xD;
      TRF high fat diet protocol, which allowed ad libitum access to the high fat diet for 2&#xD;
      consecutive days per week, simulating a &quot;weekend&quot;, lean body weights and metabolic profiles&#xD;
      were maintained [6]. These studies suggest that following a TRF protocol is of significant&#xD;
      benefit to prevent weight gain, and or to normalise the metabolic milieu.&#xD;
&#xD;
      Observational studies of individuals who undertook the Islamic ritual of fasting during the&#xD;
      month of Ramadan [7, 8]. Under these conditions, not only is the timing of food intake&#xD;
      restricted, but feeding times are switched to non-daylight hours. The outcomes from these&#xD;
      observational studies are mixed, but many have observed reduced cardiovascular risk factors&#xD;
      [7, 8]. However, beneficial changes in glycaemic profile are more controversial. One study,&#xD;
      using continuous glucose monitors, reported there was a change in the pattern of the&#xD;
      glycaemic profile, but no change in overall glycaemia [9]. Other studies have noted that&#xD;
      fasting glucose levels are increased following Ramadan [7]. Epidemiological evidence shows&#xD;
      that individuals who report consuming more of their daily energy intake at the evening meal&#xD;
      were more overweight, than those who reported consumed more of their energy intake before&#xD;
      lunch[10]. Similarly, eating lunch late in the day (after 15:00 hrs) was predictive of poorer&#xD;
      weight loss during a 20-week dietary intervention study [11] and individuals randomized to&#xD;
      consume more calories at breakfast had greater weight loss versus those randomized to eat&#xD;
      more calories at dinner after 12 weeks [12]. Taken together these data suggest that consuming&#xD;
      more calories in the morning may be beneficial for weight management.&#xD;
&#xD;
      Only a limited number of controlled studies have interrogated the effects of TRF in humans&#xD;
      [13-15]. The first was a randomised controlled cross-over intervention, where lean&#xD;
      individuals were instructed either to consume all of their calories required for weight&#xD;
      maintenance over a 4 hour period from 1700-2100h, or as 3 meals/d for 8 weeks. Consumption of&#xD;
      the evening meal was supervised within the laboratory, to ensure subjects consumed the entire&#xD;
      meal. Significant reductions in body weight and body fat mass, by 1.4 and 2.1 kg&#xD;
      respectively, were noted when following the TRF protocol [13]. Despite this small amount of&#xD;
      weight loss, fasting blood glucose levels were increased, and TRF resulted in poorer glucose&#xD;
      tolerance in response to an oral glucose tolerance test (OGTT) [14]. Thus, consuming a&#xD;
      single, large &quot;dinner&quot; meal was detrimental for metabolic health, although no differences in&#xD;
      insulin response were noted [14]. Gill et al also examined the effects of 10-11h TRF in 8 men&#xD;
      who were overweight and reported an habitual eating pattern that usually spanned at least 14&#xD;
      hours. A 3% body weight loss was observed after 2 months of TRF, and this was maintained for&#xD;
      12 months[16]. It is unclear whether responses may have differed if the food allowance was&#xD;
      prescribed at breakfast or lunch times. Finally, healthy, lean male subjects were allowed to&#xD;
      eat ad libitum for 13h per day (6am-7pm) for 2 weeks. Participants reported eating&#xD;
      significantly less on the TRF versus the control condition, and lost -0.4kg compared with a&#xD;
      gain of +0.6kg in the control condition [15]. Whilst this is a minor change in body weight,&#xD;
      this pattern is not that atypical of modern eating patterns, and further restriction of&#xD;
      eating times, and assessment of obese individuals under these conditions is warranted. The&#xD;
      metabolic health impacts were not reported in either of these studies.&#xD;
&#xD;
      Screening visit (S) - (Informed consent, screening questionnaire): Participants will be&#xD;
      assessed by a screening questionnaire (provided for review) for risk of type 2 diabetes, and&#xD;
      for their diet, medical and exercise history to determine their eligibility. Potentially&#xD;
      eligible participants will be invited to attend SAHMRI and have the research protocol&#xD;
      explained to them in detail. Informed consent to participate in the study, including a verbal&#xD;
      indication that they understand the general study protocol and requirements is then obtained.&#xD;
      Routine clinical checks are then performed (weight, height, waist circumference, blood&#xD;
      pressure). If participants meet the eligibility criteria, they will be invited to take part&#xD;
      in the study.&#xD;
&#xD;
      Baseline assessment and food intake monitoring: In this study, we will use a smartphone-based&#xD;
      monitoring and feedback tool (MyCircadianClock app) to monitor the daily pattern of ingestive&#xD;
      behaviour, activity and sleep patterns for 1-week, at baseline as well as during weeks 1,3&#xD;
      and 5. This app was developed by our collaborators at Salk Institute, Professor Satchidananda&#xD;
      Panda and Dr Emily Manoogian. Participants in our study will be asked to sign up to the&#xD;
      MyCircadianClock smartphone app and using the app are asked to take a photograph of any food&#xD;
      and drink that they consume, which time stamps when and what was eaten, for later analysis.&#xD;
      This app is part of a study conducted by Professor Panda. The Panda lab will share the&#xD;
      identifiable data collected through the app from participants of this study, once they have&#xD;
      received verification of informed consent from the participant in our study to do so. This is&#xD;
      outlined on page 4 of the SIS and consent asked on page 7 of the SIS/consent form. We have&#xD;
      attached IRB approval of the MyCircadianClock study, which explains the app in detail.&#xD;
&#xD;
      TRF: Participants will be instructed to consume their habitual diet within a self-selected 10&#xD;
      hour period every day. Outside of the selected eating period, participants are allowed to&#xD;
      consume water (encouraged to drink 6-8 glasses per day) and calorie free foods (e.g.&#xD;
      sugar-free drinks and chewing gum) as well as black coffee and/or tea. Participants will&#xD;
      track their energy intake using the application described above. This will track compliance,&#xD;
      and allow us to assess changes in intake.&#xD;
&#xD;
      Metabolic Testing (W0, W6): Participants will be provided with a standardised meal that&#xD;
      provides ~30% of their estimated total daily energy requirement (McCains Lasagne, fruit&#xD;
      salad, muesli bar) to consume the evening prior to the study visit, by 1930h. They will&#xD;
      arrive at 0730 at the Research Unit following a 12 hour overnight fast. Weight, waist and hip&#xD;
      circumference and blood pressure will be measured and a 20G cannula inserted into an&#xD;
      antecubital vein. A fasting blood sample (20 mL) is drawn for baseline measurements and to&#xD;
      assess HbA1c. A second fasting blood sample (20ml) will be taken immediately prior to&#xD;
      consuming a standardised 700kcal liquid meal (EnsurePlus ®; 57% CHO, 28 % fat, 15 % protein)&#xD;
      (t=0). 6*10 mL blood samples are drawn at 15,30,60,90,120,180 minutes to measure glucose,&#xD;
      free fatty acids, insulin, c-peptide and appetite hormones. A total volume of 100 mL blood&#xD;
      will be collected at visit 0 and 6; with a total volume of 200 mL collected over 6 weeks.&#xD;
      Appetite responses during the meal will be monitored using standardised visual analog scales.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient funding to complete pilot.&#xD;
  </why_stopped>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in glycaemia</measure>
    <time_frame>3 hours</time_frame>
    <description>Change in fasting and postprandial blood glucose following a standard meal test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>6 weeks</time_frame>
    <description>changes in body weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist and hip circumference</measure>
    <time_frame>6 weeks</time_frame>
    <description>changes in waist and hip circumference (cm) and waist:hip ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insulin</measure>
    <time_frame>3 hours</time_frame>
    <description>changes in fasting insulin and insulin response to a standard meal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in gut peptides</measure>
    <time_frame>3 hours</time_frame>
    <description>changes in fasting gut peptides and gut peptide responses to a standard meal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiovascular risk</measure>
    <time_frame>6 weeks</time_frame>
    <description>changes in blood pressure, blood lipids after 6 weeks of intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in appetite</measure>
    <time_frame>3 hours</time_frame>
    <description>changes in measures of appetite in response to a standard meal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food intake</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change in quantity and nutritional composition of food intake</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Type2 Diabetes</condition>
  <condition>Insulin Resistance</condition>
  <arm_group>
    <arm_group_label>TRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TRF</intervention_name>
    <description>Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.</description>
    <arm_group_label>TRF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        overweight (BMI &gt;25.0 kg/m2) Waist circumference &gt;102 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal history of cardiovascular disease, diabetes, major psychiatric disorders,&#xD;
             insomnia&#xD;
&#xD;
          -  use of prescribed or non-prescribed medications which may affect energy metabolism,&#xD;
             gastrointestinal function, weight or appetite (e.g. domperidone and cisapride,&#xD;
             anticholinergic drugs (e.g. atropine), androgenic medications (e.g. testosterone),&#xD;
             metoclopramide, orlistat, diuretics)&#xD;
&#xD;
          -  use of prescribed glucose-lowering/antidiabetic medication (e.g. metformin, DPP4&#xD;
             inhibitors)&#xD;
&#xD;
          -  recent weight change in past 3 months, and/or does not habitually eat breakfast&#xD;
&#xD;
          -  uncontrolled asthma, current fever, upper respiratory infections&#xD;
&#xD;
          -  individuals who regularly perform high intensity exercise (&gt;2 week)&#xD;
&#xD;
          -  current intake of &gt; 140g alcohol/week&#xD;
&#xD;
          -  current smokers of cigarettes/cigars/marijuana&#xD;
&#xD;
          -  current intake of any illicit substance&#xD;
&#xD;
          -  current shift worker&#xD;
&#xD;
          -  has donated blood within past 3-months&#xD;
&#xD;
          -  unable to comprehend study protocol&#xD;
&#xD;
          -  does not own a smartphone&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leonie Heilbronn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Adelaide</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Adelaide Medical School</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5005</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>May 23, 2018</last_update_submitted>
  <last_update_submitted_qc>May 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Adelaide</investigator_affiliation>
    <investigator_full_name>A/Prof Leonie Heilbronn</investigator_full_name>
    <investigator_title>A/Prof</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Food intake data obtained from the MyCircadianApp will be shared between the researchers and the collaborators.</ipd_description>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03278236
org study id: HREC/17/RAH/307
nct id: NCT03278236
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obesity is a serious medical condition, the adverse consequences of which include increased
      risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic
      cost of obesity was placed at $58 billion dollars in Australia in 2008 [1]. Studies in mice
      and non-human primates have shown that moderate caloric restriction (CR) increases lifespan
      and reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes [2]. Reduced
      risk of chronic diseases is also observed in humans following CR [3]. However, daily CR is
      difficult to maintain long term, since the body defends against weight loss by inducing
      "metabolic adaptation"[3] and altering the hormonal appetite response [4]. An emerging number
      of studies are examining the effects of limiting food intake to prescribed time periods per
      day, or every other day. Time restricted feeding (TRF) describes a dieting approach where
      food is available ad libitum, however only for a limited period of time (i.e. 3-12 hours).

      This pilot study will examine the effects of restricting daily food intake to within a 10
      hour period on glycaemic control, body weight and biomarkers of metabolic health for 6-weeks.
      This study will build on the existing knowledge base in humans as to whether meal timing,
      rather than caloric restriction per se, is important to provide the stimulus required to
      improve metabolic health and reduce risk of chronic disease.
The timing of meals distributed across the wake cycle may play a role in body weight
      regulation and metabolic health. In rodents, providing an 12 h feeding opportunity during the
      active phase abrogated the metabolic consequences of a high fat diet, including maintaining
      leaner body weight and normal glucose homeostasis [5]. In diet-induced obese rodents,
      switching to a TRF protocol normalised the metabolic milieu by reducing hyperinsulinemia,
      hepatic steatosis, and inflammation [6]. Interestingly, when lean animals were switched to a
      TRF high fat diet protocol, which allowed ad libitum access to the high fat diet for 2
      consecutive days per week, simulating a "weekend", lean body weights and metabolic profiles
      were maintained [6]. These studies suggest that following a TRF protocol is of significant
      benefit to prevent weight gain, and or to normalise the metabolic milieu.

      Observational studies of individuals who undertook the Islamic ritual of fasting during the
      month of Ramadan [7, 8]. Under these conditions, not only is the timing of food intake
      restricted, but feeding times are switched to non-daylight hours. The outcomes from these
      observational studies are mixed, but many have observed reduced cardiovascular risk factors
      [7, 8]. However, beneficial changes in glycaemic profile are more controversial. One study,
      using continuous glucose monitors, reported there was a change in the pattern of the
      glycaemic profile, but no change in overall glycaemia [9]. Other studies have noted that
      fasting glucose levels are increased following Ramadan [7]. Epidemiological evidence shows
      that individuals who report consuming more of their daily energy intake at the evening meal
      were more overweight, than those who reported consumed more of their energy intake before
      lunch[10]. Similarly, eating lunch late in the day (after 15:00 hrs) was predictive of poorer
      weight loss during a 20-week dietary intervention study [11] and individuals randomized to
      consume more calories at breakfast had greater weight loss versus those randomized to eat
      more calories at dinner after 12 weeks [12]. Taken together these data suggest that consuming
      more calories in the morning may be beneficial for weight management.

      Only a limited number of controlled studies have interrogated the effects of TRF in humans
      [13-15]. The first was a randomised controlled cross-over intervention, where lean
      individuals were instructed either to consume all of their calories required for weight
      maintenance over a 4 hour period from 1700-2100h, or as 3 meals/d for 8 weeks. Consumption of
      the evening meal was supervised within the laboratory, to ensure subjects consumed the entire
      meal. Significant reductions in body weight and body fat mass, by 1.4 and 2.1 kg
      respectively, were noted when following the TRF protocol [13]. Despite this small amount of
      weight loss, fasting blood glucose levels were increased, and TRF resulted in poorer glucose
      tolerance in response to an oral glucose tolerance test (OGTT) [14]. Thus, consuming a
      single, large "dinner" meal was detrimental for metabolic health, although no differences in
      insulin response were noted [14]. Gill et al also examined the effects of 10-11h TRF in 8 men
      who were overweight and reported an habitual eating pattern that usually spanned at least 14
      hours. A 3% body weight loss was observed after 2 months of TRF, and this was maintained for
      12 months[16]. It is unclear whether responses may have differed if the food allowance was
      prescribed at breakfast or lunch times. Finally, healthy, lean male subjects were allowed to
      eat ad libitum for 13h per day (6am-7pm) for 2 weeks. Participants reported eating
      significantly less on the TRF versus the control condition, and lost -0.4kg compared with a
      gain of +0.6kg in the control condition [15]. Whilst this is a minor change in body weight,
      this pattern is not that atypical of modern eating patterns, and further restriction of
      eating times, and assessment of obese individuals under these conditions is warranted. The
      metabolic health impacts were not reported in either of these studies.

      Screening visit (S) - (Informed consent, screening questionnaire): Participants will be
      assessed by a screening questionnaire (provided for review) for risk of type 2 diabetes, and
      for their diet, medical and exercise history to determine their eligibility. Potentially
      eligible participants will be invited to attend SAHMRI and have the research protocol
      explained to them in detail. Informed consent to participate in the study, including a verbal
      indication that they understand the general study protocol and requirements is then obtained.
      Routine clinical checks are then performed (weight, height, waist circumference, blood
      pressure). If participants meet the eligibility criteria, they will be invited to take part
      in the study.

      Baseline assessment and food intake monitoring: In this study, we will use a smartphone-based
      monitoring and feedback tool (MyCircadianClock app) to monitor the daily pattern of ingestive
      behaviour, activity and sleep patterns for 1-week, at baseline as well as during weeks 1,3
      and 5. This app was developed by our collaborators at Salk Institute, Professor Satchidananda
      Panda and Dr Emily Manoogian. Participants in our study will be asked to sign up to the
      MyCircadianClock smartphone app and using the app are asked to take a photograph of any food
      and drink that they consume, which time stamps when and what was eaten, for later analysis.
      This app is part of a study conducted by Professor Panda. The Panda lab will share the
      identifiable data collected through the app from participants of this study, once they have
      received verification of informed consent from the participant in our study to do so. This is
      outlined on page 4 of the SIS and consent asked on page 7 of the SIS/consent form. We have
      attached IRB approval of the MyCircadianClock study, which explains the app in detail.

      TRF: Participants will be instructed to consume their habitual diet within a self-selected 10
      hour period every day. Outside of the selected eating period, participants are allowed to
      consume water (encouraged to drink 6-8 glasses per day) and calorie free foods (e.g.
      sugar-free drinks and chewing gum) as well as black coffee and/or tea. Participants will
      track their energy intake using the application described above. This will track compliance,
      and allow us to assess changes in intake.

      Metabolic Testing (W0, W6): Participants will be provided with a standardised meal that
      provides ~30% of their estimated total daily energy requirement (McCains Lasagne, fruit
      salad, muesli bar) to consume the evening prior to the study visit, by 1930h. They will
      arrive at 0730 at the Research Unit following a 12 hour overnight fast. Weight, waist and hip
      circumference and blood pressure will be measured and a 20G cannula inserted into an
      antecubital vein. A fasting blood sample (20 mL) is drawn for baseline measurements and to
      assess HbA1c. A second fasting blood sample (20ml) will be taken immediately prior to
      consuming a standardised 700kcal liquid meal (EnsurePlus ®; 57% CHO, 28 % fat, 15 % protein)
      (t=0). 6*10 mL blood samples are drawn at 15,30,60,90,120,180 minutes to measure glucose,
      free fatty acids, insulin, c-peptide and appetite hormones. A total volume of 100 mL blood
      will be collected at visit 0 and 6; with a total volume of 200 mL collected over 6 weeks.
      Appetite responses during the meal will be monitored using standardised visual analog scales.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in glycaemia
time frame: 3 hours
description: Change in fasting and postprandial blood glucose following a standard meal test
measure: Change in HbA1c
time frame: 6 weeks
measure: Change in body weight
time frame: 6 weeks
description: changes in body weight (kg)
measure: Change in waist and hip circumference
time frame: 6 weeks
description: changes in waist and hip circumference (cm) and waist:hip ratio
measure: Change in insulin
time frame: 3 hours
description: changes in fasting insulin and insulin response to a standard meal
measure: Change in gut peptides
time frame: 3 hours
description: changes in fasting gut peptides and gut peptide responses to a standard meal
measure: Change in cardiovascular risk
time frame: 6 weeks
description: changes in blood pressure, blood lipids after 6 weeks of intervention
measure: Change in appetite
time frame: 3 hours
description: changes in measures of appetite in response to a standard meal
measure: Change in food intake
time frame: 6 weeks
description: Change in quantity and nutritional composition of food intake
arm group label: TRF
arm group type: Experimental
intervention type: Behavioral
intervention name: TRF
description: Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.
arm group label: TRF
criteria: 
gender: Male
gender based: Yes
minimum age: 45 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Leonie Heilbronn, PhD
role: Principal Investigator
affiliation: University of Adelaide
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: University of Adelaide
investigator full name: A/Prof Leonie Heilbronn
investigator title: A/Prof
mesh term: Overweight
mesh term: Insulin Resistance
sharing ipd: Yes
ipd description: Food intake data obtained from the MyCircadianApp will be shared between the researchers and the collaborators.
ipd info type: Informed Consent Form (ICF)