CHRONOtype-adjusted DIET on Weight Loss

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: CHRONOTYPE-ADJUSTED DIET

• Registration Number: NCT03755674
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-10
• Primary Completion: 2016-12-21
• Study Completion: 2017-02-23
• Study First Submitted: 2018-07-19
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-25
• Last Update Submitted: 2018-11-25
• Study First Posted: 2018-11-28
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHRONOTYPE-ADJUSTED DIET	CHRONOTYPE-ADJUSTED DIET	Patients that undergo a chronotype adjusted diet

Primary Outcome Measures

Name	Time	Method
Total weight loss, in percentage, from baseline to end-of-treatment	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

Name	Time	Method
Anthropometrical and other clinical parameters	12 weeks	Improvement of anthropometrical and other clinical parameters during the treatment
BMI loss	12 weeks	BMI decrease from baseline