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CHRONOtype-adjusted DIET on Weight Loss (CHRONO-DIET)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CHRONOTYPE-ADJUSTED DIET
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Appetite regulation, Chronotype, Diet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • students or staff of the Catholic University of Murcia (UCAM), with an age ranged between 18 and 65 years old

Exclusion Criteria:

  • clinically significant illnesses (including type 2 diabetes, chronic heart failure, hepatitis and cancer)
  • those taking any medications known to affect body weight (thyroid hormones, corticosteroids, etc.)
  • women in special physiological situations (pregnant, lactating).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CHRONOTYPE-ADJUSTED DIET

    CONTROL

    Arm Description

    Patients that undergo a chronotype adjusted diet

    Patients following a traditional or conventional hypocaloric diet

    Outcomes

    Primary Outcome Measures

    Total weight loss, in percentage, from baseline to end-of-treatment
    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.

    Secondary Outcome Measures

    BMI loss
    BMI decrease from baseline
    Anthropometrical and other clinical parameters
    Improvement of anthropometrical and other clinical parameters during the treatment

    Full Information

    First Posted
    July 19, 2018
    Last Updated
    November 25, 2018
    Sponsor
    Universidad Católica San Antonio de Murcia
    Collaborators
    Hospital Universitario Virgen de la Arrixaca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03755674
    Brief Title
    CHRONOtype-adjusted DIET on Weight Loss
    Acronym
    CHRONO-DIET
    Official Title
    Influence of Chronobiological and Neuroendocrine Factors in Appetite Regulation and Obesity Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2015 (Actual)
    Primary Completion Date
    December 21, 2016 (Actual)
    Study Completion Date
    February 23, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Católica San Antonio de Murcia
    Collaborators
    Hospital Universitario Virgen de la Arrixaca

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    Obesity, Appetite regulation, Chronotype, Diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CHRONOTYPE-ADJUSTED DIET
    Arm Type
    Experimental
    Arm Description
    Patients that undergo a chronotype adjusted diet
    Arm Title
    CONTROL
    Arm Type
    No Intervention
    Arm Description
    Patients following a traditional or conventional hypocaloric diet
    Intervention Type
    Procedure
    Intervention Name(s)
    CHRONOTYPE-ADJUSTED DIET
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Total weight loss, in percentage, from baseline to end-of-treatment
    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.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    BMI loss
    Description
    BMI decrease from baseline
    Time Frame
    12 weeks
    Title
    Anthropometrical and other clinical parameters
    Description
    Improvement of anthropometrical and other clinical parameters during the treatment
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: students or staff of the Catholic University of Murcia (UCAM), with an age ranged between 18 and 65 years old Exclusion Criteria: clinically significant illnesses (including type 2 diabetes, chronic heart failure, hepatitis and cancer) those taking any medications known to affect body weight (thyroid hormones, corticosteroids, etc.) women in special physiological situations (pregnant, lactating).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan José Hernández Morante, PhD
    Organizational Affiliation
    Universidad Católica San Antonio de Murcia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31153674
    Citation
    Galindo Munoz JS, Gomez Gallego M, Diaz Soler I, Barbera Ortega MC, Martinez Caceres CM, Hernandez Morante JJ. Effect of a chronotype-adjusted diet on weight loss effectiveness: A randomized clinical trial. Clin Nutr. 2020 Apr;39(4):1041-1048. doi: 10.1016/j.clnu.2019.05.012. Epub 2019 May 21.
    Results Reference
    derived

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    CHRONOtype-adjusted DIET on Weight Loss

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