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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03755674
Recruitment Status : Completed
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborator:
Hospital Universitario Virgen de la Arrixaca
Information provided by (Responsible Party):
Juan Jose Hernández Morante, Universidad Católica San Antonio de Murcia

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.


Condition or disease Intervention/treatment Phase
Obesity Procedure: CHRONOTYPE-ADJUSTED DIET Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Chronobiological and Neuroendocrine Factors in Appetite Regulation and Obesity Treatment
Actual Study Start Date : January 10, 2015
Actual Primary Completion Date : December 21, 2016
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CHRONOTYPE-ADJUSTED DIET
Patients that undergo a chronotype adjusted diet
Procedure: CHRONOTYPE-ADJUSTED DIET
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.

No Intervention: CONTROL
Patients following a traditional or conventional hypocaloric diet



Primary Outcome Measures :
  1. Total weight loss, in percentage, from baseline to end-of-treatment [ Time Frame: 12 weeks ]
    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 :
  1. BMI loss [ Time Frame: 12 weeks ]
    BMI decrease from baseline

  2. Anthropometrical and other clinical parameters [ Time Frame: 12 weeks ]
    Improvement of anthropometrical and other clinical parameters during the treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755674


Sponsors and Collaborators
Universidad Católica San Antonio de Murcia
Hospital Universitario Virgen de la Arrixaca
Investigators
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Principal Investigator: Juan José Hernández Morante, PhD Universidad Católica San Antonio de Murcia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Juan Jose Hernández Morante, Principal Investigator of Eating Disorders Research Unit, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier: NCT03755674    
Other Study ID Numbers: PMAFI14/12-1
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan Jose Hernández Morante, Universidad Católica San Antonio de Murcia:
Obesity
Appetite regulation
Chronotype
Diet
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight