CHRONOtype-adjusted DIET on Weight Loss (CHRONO-DIET)
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|ClinicalTrials.gov Identifier: NCT03755674|
Recruitment Status : Completed
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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
- 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.
- BMI loss [ Time Frame: 12 weeks ]BMI decrease from baseline
- Anthropometrical and other clinical parameters [ Time Frame: 12 weeks ]Improvement of anthropometrical and other clinical parameters during the treatment
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
|Principal Investigator:||Juan José Hernández Morante, PhD||Universidad Católica San Antonio de Murcia|