CHRONOtype-adjusted DIET on Weight Loss

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Chronobiological and Neuroendocrine Factors in Appetite Regulation and Obesity Treatment

Conditions
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Obesity

Intervention / Treatment
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* Procedure: CHRONOTYPE-ADJUSTED DIET


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHRONOTYPE-ADJUSTED DIET<br>Patients that undergo a chronotype adjusted diet | Procedure: CHRONOTYPE-ADJUSTED DIET<br>* 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.<br>|
| No Intervention: CONTROL<br>Patients following a traditional or conventional hypocaloric diet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI loss | BMI decrease from baseline | 12 weeks | 
| Anthropometrical and other clinical parameters | Improvement of anthropometrical and other clinical parameters during the treatment | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Appetite regulation, Chronotype, Diet