Chronobiology and Childhood Obesity in a Mediterranean Spanish Population

Obesity Clinical Trial

— ONTIME-JR  

Official title:

Chronobiology and Childhood Obesity in a Mediterranean Spanish Population (ONTIME-JR: Obesity, Nutrigenomics, Timing, Mediterranean, Junior)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895282
• Other study ID #: SAF2014-52480-R
• Status: Completed
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: March 2020
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective is to investigate chronobiological aspects of childhood obesity studying the potential relationship between meal patterns and circadian rhythmicity in a cross-sectional sample of obese, overweight and normal weight children/adolescent.

Description:

Childhood obesity has more than doubled in children and tripled in adolescents in the past 30 y. As consequence, increasingly children and adolescents suffer from elevated blood pressure, impaired glucose tolerance, hyperinsulinemia, dyslipidemia. Obesity has a multifactorial etiology since there are potentially numerous contributors to its development and progression. Chronobiology, the science that studies periodic (cyclic) changes in living organisms, has been recently proposed as a new and promising topic to investigate. Alterations of circadian (24 h oscillations) system may contribute to obesity and its complications development such as high blood pressure, insulin resistance, altered fasting lipid profile. Conversely, in a vicious manner, obesity has been regarded as a fault in the circadian system explainable by the association with imbalances and fluctuations of hormones/genes expressions rhythms under the influence of body weight changes.

Thus, the study will examine changes in circadian rhythmicity over a week period. The primary end point will be to evaluate differences between obese/overweight and non-obese children in chronotypes and the responses of these parameters to meal patterns. In particular, non-invasive measures that are well-established determinants of chronotypes will form the core endpoints for the study. Well designed and age-appropriate questionnaires will provide further information in order to study correlations with eating, sleeping and sedentary/active behaviors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Age: 8-12 years of age

• Children from schools in the region of Murcia (Spain) who enter voluntarily

Exclusion Criteria:

• Children who take melatonin or sleep drugs

Related Conditions & MeSH terms

• Chronobiology Disorders
• Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
Spain	Chronobiology laboratory, Department of Physiology	Murcia
Spain	University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	A key index for relating weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared.	At baseline
Secondary	Individual chronotype with the Munich ChronoType Questionnaire	To assess chronotype with a questionnaire that establishes an algorithm which optimises chronotype assessment by incorporating the information on timing of sleep and wakefulness for both work and free days. The timing and duration of sleep are generally independent. However, when the two are analysed separately for work and free days, sleep duration strongly depends on chronotype. In addition, chronotype is both age- and sex-dependent.	At baseline
Secondary	Wrist temperature rhythm	Wrist temperature wireless recording is considered a reliable procedure to evaluate circadian rhythmicity, and an index to establish and follow the effects of chronotherapy in normal living subjects.	At baseline
Secondary	Rest-activity rhythm	Rest-activity rhythm as assessed using a acceleration data logger UA-004-64 (Onset Computer, Bourne, MA, USA) placed on the non-dominant arm by means of a sports band, with its x axis parallel to the humerus bone. The sensor is programmed to record data every 30 s.	At baseline
Secondary	Sleeping characteristics with a 7 days dietary record of night time and day time (siesta) information	24hs record of sleep will be completed during the 7 days of the experiment. Children are instructed to keep a sleep and food diary designed by the University of Murcia Chronobiology Laboratory. The following data will be obtained for every subject on a daily basis: time to bed, time of lights off, nocturnal awakenings lasting more than 10 minutes, sleep offset, the time the participant arose.	At baseline
Secondary	Salivary cortisol determinations	Saliva for cortisol measurements is obtained before breakfast (09:00 h), lunch time (14:00 h), and bedtime (23:00 h) the 6th the 7th day of the experimental week using the Salivette system. Cortisol is measured with radioimmunoassay.	At baseline
Secondary	Salivary melatonin determinations on weekends the 6th and 7th day of the experimental week	Samples for the measurement of salivary melatonin are obtained before lunch (14:00 h) and at night (1:00 h) the 6th and 7th day of the experimental week.	At baseline
Secondary	Food habits with a 7 days dietary record	During the week of the experiment. Data will be obtained for every subject on a daily basis and they will record the variety of foods that they eat with the portion size.	At baseline
Secondary	Total energy intake	During the week of the experiment with a software designed for this purpose.	At baseline
Secondary	Macronutrient distribution	from the 7 days dietary record, with a software designed for this purpose.	At baseline
Secondary	Food variety	from the 7 days dietary record, with a software designed for this purpose.	At baseline
Secondary	Glycemic Index	from the 7 days dietary record, with a software designed for this purpose.	At baseline
Secondary	Physical activity	from the 7 days dietary record, with a software designed for this purpose.	Through study completion
Secondary	Mediterranean Diet Score	From the 7 days dietary record, with a software designed for this purpose.	At baseline
Secondary	Food timing with a 7 days dietary record	Children will be instructed to keep a food diary. Data will be obtained for every subject on a daily basis and they will record the time of the three main meals (breakfast, lunch, and dinner).	At baseline
Secondary	Light determination	During the week of the experiment with a light detector device in the neck of the children.	At baseline
Secondary	DNA collection in saliva	Saliva will be collected to further extraction of DNA the 7th day of the experimental week.	At baseline
Secondary	Saliva collection for microflora determinations	Saliva Collection Method is the SalivaBio Oral Swab the 7th day of the experimental week.	At baseline