Clinical Trial: Chronobiology and Childhood Obesity in a Mediterranean Spanish Population

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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.

Detailed Summary:

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.

Current Primary Outcome: BMI [ Time Frame: At baseline ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Individual chronotype with the Munich ChronoType Questionnaire [ Time Frame: At baseline ]
  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.
• Wrist temperature rhythm [ Time Frame: At baseline ]
  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.
• Rest-activity rhythm [ Time Frame: At baseline ]
  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.
• Sleeping characteristics with a 7 days dietary record of night time and day time (siesta) information [ Time Frame: At baseline ]
  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.
• Salivary cortisol determinations [ Time Frame: At baseline ]
  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.
• Salivary melatonin determinations on weekends the 6th and 7th day of the experimental week [ Time Frame: At baseline ]
  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.
• Food habits with a 7 days dietary record [ Time Frame: At baseline ]
  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.
• Total energy intake [ Time Frame: At baseline ]
  During the week of the experiment with a software designed for this purpose.
• Macronutrient distribution [ Time Frame: At baseline ]
  from the 7 days dietary record, with a software designed for this purpose.
• Food variety [ Time Frame: At baseline ]
  from the 7 days dietary record, with a software designed for this purpose.
• Glycemic Index [ Time Frame: At baseline ]
  from the 7 days dietary record, with a software designed for this purpose.
• Physical activity [ Time Frame: Through study completion ]
  from the 7 days dietary record, with a software designed for this purpose.
• Mediterranean Diet Score [ Time Frame: At baseline ]
  From the 7 days dietary record, with a software designed for this purpose.
• Food timing with a 7 days dietary record [ Time Frame: At baseline ]
  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).
• Light determination [ Time Frame: At baseline ]
  During the week of the experiment with a light detector device in the neck of the children.
• DNA collection in saliva [ Time Frame: At baseline ]
  Saliva will be collected to further extraction of DNA the 7th day of the experimental week.
• Saliva collection for microflora determinations [ Time Frame: At baseline ]
  Saliva Collection Method is the SalivaBio Oral Swab the 7th day of the experimental week.

Original Secondary Outcome: Same as current

Information By: Universidad de Murcia

Dates:
Date Received: June 30, 2016
Date Started: October 2014
Date Completion: December 2017
Last Updated: September 5, 2016
Last Verified: September 2016