CHRONOtype-adjusted DIET on Weight Loss

Obesity Clinical Trial

— CHRONO-DIET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755674
• Other study ID #: PMAFI14/12-1
• Status: Completed
• Phase: N/A
• Start date: January 10, 2015
• Est. completion date: February 23, 2017

Study information

• Verified date: November 2018
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 23, 2017
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia	Hospital Universitario Virgen de la Arrixaca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	BMI loss	BMI decrease from baseline	12 weeks
Secondary	Anthropometrical and other clinical parameters	Improvement of anthropometrical and other clinical parameters during the treatment	12 weeks