<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/NCT03755674</url>
  </required_header>
  <id_info>
    <org_study_id>PMAFI14/12-1</org_study_id>
    <nct_id>NCT03755674</nct_id>
  </id_info>
  <brief_title>CHRONOtype-adjusted DIET on Weight Loss</brief_title>
  <acronym>CHRONO-DIET</acronym>
  <official_title>Influence of Chronobiological and Neuroendocrine Factors in Appetite Regulation and Obesity Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Católica San Antonio de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario Virgen de la Arrixaca</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Católica San Antonio de Murcia</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>
      BACKGROUND: Several reports have observed that the alteration of normal biological rhythms is&#xD;
      associated with obesity development. In this regard, those subject with the preference for&#xD;
      evening seems to be prone to develop obesity. However, the current treatment of obesity does&#xD;
      not take into account these aspects OBJECTIVE: To evaluate whether a diet adjusted to&#xD;
      patient's chronotype is more effective than the current dietary recommendations.&#xD;
&#xD;
      SUBJECTS/METHODS: 209 subjects take part in a randomized, double-blind clinical trial. 104&#xD;
      subjects followed a typical hypocaloric dietary treatment (CONTROL) and the other 105&#xD;
      subjects undergone a diet with a daily caloric distribution adjusted to their chronotype&#xD;
      (CHRONO).&#xD;
&#xD;
      CONCLUSIONS: A chronotype-adjusted diet may be a promising alternative to the classical&#xD;
      hypocaloric dietary treatment since the investigator's data indicate a higher effectiveness&#xD;
      regarding weight loss when the diet was adjusted to the patient's chronotype.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2015</start_date>
  <completion_date type="Actual">February 23, 2017</completion_date>
  <primary_completion_date type="Actual">December 21, 2016</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total weight loss, in percentage, from baseline to end-of-treatment</measure>
    <time_frame>12 weeks</time_frame>
    <description>Percentage of weight loss, measured with a scale, from baseline weight (100% body weight) since body weight after 12 weeks of treatment (final body weight). Percentage of body weight was then measured as Total Weight Loss (%) = (Final body weight - Baseline body weight) / baseline body weight x 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI loss</measure>
    <time_frame>12 weeks</time_frame>
    <description>BMI decrease from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometrical and other clinical parameters</measure>
    <time_frame>12 weeks</time_frame>
    <description>Improvement of anthropometrical and other clinical parameters during the treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>CHRONOTYPE-ADJUSTED DIET</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients that undergo a chronotype adjusted diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients following a traditional or conventional hypocaloric diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CHRONOTYPE-ADJUSTED DIET</intervention_name>
    <description>Those patients followed a daily caloric distribution attending to their chronotype. In this regards, 'morning' subjects ate a higher quantity of calories at the first part of the day, while 'evening' subjects ate a higher amount of calories at the second half of the day.</description>
    <arm_group_label>CHRONOTYPE-ADJUSTED DIET</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  students or staff of the Catholic University of Murcia (UCAM), with an age ranged&#xD;
             between 18 and 65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinically significant illnesses (including type 2 diabetes, chronic heart failure,&#xD;
             hepatitis and cancer)&#xD;
&#xD;
          -  those taking any medications known to affect body weight (thyroid hormones,&#xD;
             corticosteroids, etc.)&#xD;
&#xD;
          -  women in special physiological situations (pregnant, lactating).&#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>Juan José Hernández Morante, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Católica San Antonio de Murcia</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 25, 2018</last_update_submitted>
  <last_update_submitted_qc>November 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica San Antonio de Murcia</investigator_affiliation>
    <investigator_full_name>Juan Jose Hernández Morante</investigator_full_name>
    <investigator_title>Principal Investigator of Eating Disorders Research Unit</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Appetite regulation</keyword>
  <keyword>Chronotype</keyword>
  <keyword>Diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <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/NCT03755674
org study id: PMAFI14/12-1
nct id: NCT03755674
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
BACKGROUND: Several reports have observed that the alteration of normal biological rhythms is
      associated with obesity development. In this regard, those subject with the preference for
      evening seems to be prone to develop obesity. However, the current treatment of obesity does
      not take into account these aspects OBJECTIVE: To evaluate whether a diet adjusted to
      patient's chronotype is more effective than the current dietary recommendations.

      SUBJECTS/METHODS: 209 subjects take part in a randomized, double-blind clinical trial. 104
      subjects followed a typical hypocaloric dietary treatment (CONTROL) and the other 105
      subjects undergone a diet with a daily caloric distribution adjusted to their chronotype
      (CHRONO).

      CONCLUSIONS: A chronotype-adjusted diet may be a promising alternative to the classical
      hypocaloric dietary treatment since the investigator's data indicate a higher effectiveness
      regarding weight loss when the diet was adjusted to the patient's chronotype.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Total weight loss, in percentage, from baseline to end-of-treatment
time frame: 12 weeks
description: Percentage of weight loss, measured with a scale, from baseline weight (100% body weight) since body weight after 12 weeks of treatment (final body weight). Percentage of body weight was then measured as Total Weight Loss (%) = (Final body weight - Baseline body weight) / baseline body weight x 100.
measure: BMI loss
time frame: 12 weeks
description: BMI decrease from baseline
measure: Anthropometrical and other clinical parameters
time frame: 12 weeks
description: Improvement of anthropometrical and other clinical parameters during the treatment
arm group label: CHRONOTYPE-ADJUSTED DIET
arm group type: Experimental
description: Patients that undergo a chronotype adjusted diet
arm group label: CONTROL
arm group type: No Intervention
description: Patients following a traditional or conventional hypocaloric diet
intervention type: Procedure
intervention name: CHRONOTYPE-ADJUSTED DIET
description: Those patients followed a daily caloric distribution attending to their chronotype. In this regards, 'morning' subjects ate a higher quantity of calories at the first part of the day, while 'evening' subjects ate a higher amount of calories at the second half of the day.
arm group label: CHRONOTYPE-ADJUSTED DIET
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Juan José Hernández Morante, PhD
role: Principal Investigator
affiliation: Universidad Católica San Antonio de Murcia
responsible party type: Principal Investigator
investigator affiliation: Universidad Católica San Antonio de Murcia
investigator full name: Juan Jose Hernández Morante
investigator title: Principal Investigator of Eating Disorders Research Unit
mesh term: Obesity
sharing ipd: No