<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/NCT03003936</url>
  </required_header>
  <id_info>
    <org_study_id>15123/PI/10</org_study_id>
    <nct_id>NCT03003936</nct_id>
  </id_info>
  <brief_title>Glucose Tolerance, Meal Timing and MTNR1B</brief_title>
  <acronym>ONTIME-DINE</acronym>
  <official_title>Glucose Tolerance, Meal Timing and MTNR1B in a Mediterranean Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Murcia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this investigation is to assess in a community-based cohort of late-night&#xD;
      eaters the effect of coincident food intake and endogenous melatonin on glycemic control, and&#xD;
      the putative interaction effect of melatonin receptor 1B (MTNR1B) genetic variation on this&#xD;
      relationship. With the results from this study, the investigators expect to advance in the&#xD;
      understanding of the role of endogenous melatonin on glucose metabolism in late night eaters&#xD;
      and carriers of the MTNR1B risk allele, with potential implications on the guidelines to&#xD;
      mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Late-night dinner eating is associated with increased risk for type-2-diabetes. The&#xD;
      underlying mechanism is unclear. One explanatory hypothesis is that the concurrence of&#xD;
      elevated circulating melatonin and high glucose concentrations (characterizing late-eating)&#xD;
      leads to impaired glucose-tolerance. However, to date, no study has tested the influence of&#xD;
      physiological melatonin concentrations on glucose tolerance. The discovery of melatonin&#xD;
      receptor MTNR1B as a diabetes risk gene provides evidence for a role of physiological levels&#xD;
      of melatonin in glucose control.&#xD;
&#xD;
      The aim of the current study is to test the hypothesis that the concurrence of meal timing&#xD;
      with elevated endogenous melatonin concentrations results in impaired glucose control and&#xD;
      that this effect is stronger in homozygous MTNR1B risk carriers than in non-carriers. To do&#xD;
      so we will test glucose tolerance using identical mixed meals under two dinner conditions: a)&#xD;
      delayed dinner or Late Eating (LE): starting1 hour before usual bed time, b) advanced dinner&#xD;
      or Early Eating (EE): starting 4 hours before habitual bed time, in a randomized, cross-over&#xD;
      study design.&#xD;
&#xD;
      These findings could support a clinical application for the screening of this single&#xD;
      nucleotide polymorphism (SNP) and the possibility of implementing tailored and cost-effective&#xD;
      behavioral interventions to prevent type 2 diabetes in vulnerable populations.&#xD;
&#xD;
      These goals will be achieved through a specific approach:&#xD;
&#xD;
      • Interventional (randomized, cross-over controlled trials) (Aim 1): To study the potential&#xD;
      interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Curve (AUC) glucose</measure>
    <time_frame>between 0-120 minutes, Visit 2 and 3</time_frame>
    <description>Investigators will measure glucose levels for 120 minutes at day time and night time visits, and compare the results by genotype at selected loci.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting glucose</measure>
    <time_frame>between 0-120 minutes, Visit 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saliva Melatonin</measure>
    <time_frame>between 0-120 minutes, Visit 2 and 3</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Sleep Duration</measure>
    <time_frame>total of 2 weeks between Visit 1 and 3</time_frame>
    <description>Sleep duration will be computed from self-reported.</description>
  </other_outcome>
  <other_outcome>
    <measure>Light Exposure</measure>
    <time_frame>total of 2 weeks between Visit 1 and 3</time_frame>
    <description>Measured using Pendant G Acceleration Data Logger.</description>
  </other_outcome>
  <other_outcome>
    <measure>Total Energy Intake</measure>
    <time_frame>total of 2 weeks between Visit 1 and 3</time_frame>
    <description>Total energy intake in kcal/day will be computed from 14-day 24-hr dietary record.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dietary Composition</measure>
    <time_frame>total of 2 weeks between Visit 1 and 3</time_frame>
    <description>Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary record.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dietary Intake Timing</measure>
    <time_frame>total of 2 weeks between Visit 1 and 3</time_frame>
    <description>Food timing will be self-reported and averaged across 14-days of 24-hr dietary record.</description>
  </other_outcome>
  <other_outcome>
    <measure>Chronotype</measure>
    <time_frame>at baseline</time_frame>
    <description>Assessed using the Morningness-Eveningness Questionnaire (MEQ).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Non-Diabetic Disorder of Endocrine Pancreas</condition>
  <arm_group>
    <arm_group_label>Early Dinner Timing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test the lack of concurrence of meal timing with endogenous melatonin concentrations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late Dinner Timing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test the concurrence of meal timing with elevated endogenous melatonin concentrations</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dinner timing</intervention_name>
    <description>Glucose tolerance after a late diner (1 hour before habitual bedtime) differs from early dinner (4 hours before habitual bedtime) due to the concurrence of meal timing with different levels of endogenous melatonin. This effect can be different among risk allele carriers (G) or non-rick allele carriers (C) of the MTNR1B.</description>
    <arm_group_label>Early Dinner Timing</arm_group_label>
    <arm_group_label>Late Dinner Timing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index: &gt;19 kg/m2&#xD;
&#xD;
          -  Age: &gt;18 years of age&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving treatment with thermogenic, lipogenic, or contraceptive drugs&#xD;
&#xD;
          -  Diabetes mellitus, chronic renal failure, hepatic diseases, or cancer diagnosis&#xD;
&#xD;
          -  Bulimia diagnosis, prone to binge eating&#xD;
&#xD;
          -  Undergoing treatment with anxiolytic or antidepressant drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marta Garaulet, PHD</last_name>
    <role>Study Director</role>
    <affiliation>Universidad de Murcia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Murcia</name>
      <address>
        <city>Murcia</city>
        <zip>30100</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>October 26, 2017</last_update_submitted>
  <last_update_submitted_qc>October 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Murcia</investigator_affiliation>
    <investigator_full_name>PROF. MARTA GARAULET AZA</investigator_full_name>
    <investigator_title>Full Proffesor</investigator_title>
  </responsible_party>
  <keyword>Glucose tolerance</keyword>
  <keyword>MTNR1B</keyword>
  <keyword>nutrigenomics</keyword>
  <keyword>Food timing</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03003936
org study id: 15123/PI/10
nct id: NCT03003936
lead sponsor: 
has dmc: Yes
The purpose of this investigation is to assess in a community-based cohort of late-night
      eaters the effect of coincident food intake and endogenous melatonin on glycemic control, and
      the putative interaction effect of melatonin receptor 1B (MTNR1B) genetic variation on this
      relationship. With the results from this study, the investigators expect to advance in the
      understanding of the role of endogenous melatonin on glucose metabolism in late night eaters
      and carriers of the MTNR1B risk allele, with potential implications on the guidelines to
      mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.
Late-night dinner eating is associated with increased risk for type-2-diabetes. The
      underlying mechanism is unclear. One explanatory hypothesis is that the concurrence of
      elevated circulating melatonin and high glucose concentrations (characterizing late-eating)
      leads to impaired glucose-tolerance. However, to date, no study has tested the influence of
      physiological melatonin concentrations on glucose tolerance. The discovery of melatonin
      receptor MTNR1B as a diabetes risk gene provides evidence for a role of physiological levels
      of melatonin in glucose control.

      The aim of the current study is to test the hypothesis that the concurrence of meal timing
      with elevated endogenous melatonin concentrations results in impaired glucose control and
      that this effect is stronger in homozygous MTNR1B risk carriers than in non-carriers. To do
      so we will test glucose tolerance using identical mixed meals under two dinner conditions: a)
      delayed dinner or Late Eating (LE): starting1 hour before usual bed time, b) advanced dinner
      or Early Eating (EE): starting 4 hours before habitual bed time, in a randomized, cross-over
      study design.

      These findings could support a clinical application for the screening of this single
      nucleotide polymorphism (SNP) and the possibility of implementing tailored and cost-effective
      behavioral interventions to prevent type 2 diabetes in vulnerable populations.

      These goals will be achieved through a specific approach:

      • Interventional (randomized, cross-over controlled trials) (Aim 1): To study the potential
      interaction between meal timing (dinner) and genetic variants MTNR1B for glucose tolerance.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Area Under the Curve (AUC) glucose
time frame: between 0-120 minutes, Visit 2 and 3
description: Investigators will measure glucose levels for 120 minutes at day time and night time visits, and compare the results by genotype at selected loci.
measure: Fasting glucose
time frame: between 0-120 minutes, Visit 2 and 3
measure: Saliva Melatonin
time frame: between 0-120 minutes, Visit 2 and 3
measure: Sleep Duration
time frame: total of 2 weeks between Visit 1 and 3
description: Sleep duration will be computed from self-reported.
measure: Light Exposure
time frame: total of 2 weeks between Visit 1 and 3
description: Measured using Pendant G Acceleration Data Logger.
measure: Total Energy Intake
time frame: total of 2 weeks between Visit 1 and 3
description: Total energy intake in kcal/day will be computed from 14-day 24-hr dietary record.
measure: Dietary Composition
time frame: total of 2 weeks between Visit 1 and 3
description: Macronutrient and micronutrient intake will be computed from 14-days of self-reported 24-hr dietary record.
measure: Dietary Intake Timing
time frame: total of 2 weeks between Visit 1 and 3
description: Food timing will be self-reported and averaged across 14-days of 24-hr dietary record.
measure: Chronotype
time frame: at baseline
description: Assessed using the Morningness-Eveningness Questionnaire (MEQ).
arm group label: Early Dinner Timing
arm group type: Experimental
description: Test the lack of concurrence of meal timing with endogenous melatonin concentrations
arm group label: Late Dinner Timing
arm group type: Experimental
description: Test the concurrence of meal timing with elevated endogenous melatonin concentrations
intervention type: Behavioral
intervention name: Dinner timing
description: Glucose tolerance after a late diner (1 hour before habitual bedtime) differs from early dinner (4 hours before habitual bedtime) due to the concurrence of meal timing with different levels of endogenous melatonin. This effect can be different among risk allele carriers (G) or non-rick allele carriers (C) of the MTNR1B.
arm group label: Early Dinner Timing
arm group label: Late Dinner Timing
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marta Garaulet, PHD
role: Study Director
affiliation: Universidad de Murcia
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Murcia
investigator full name: PROF. MARTA GARAULET AZA
investigator title: Full Proffesor
sharing ipd: No