Clinical trial NCT02895282: Chronobiology and Childhood Obesity in a Mediterranean Spanish Population
Official title: Chronobiology and Childhood Obesity in a Mediterranean Spanish Population (ONTIME-JR: Obesity, Nutrigenomics, Timing, Mediterranean, Junior)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Chronobiology Disorders
Keywords: Obesity
Chronobiology
Circadian
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 500
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children from schools who enter voluntarily in Spanish city of Murcia, located on the Southeast coast of the Mediterranean Sea.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: BMI
timeFrame: At baseline
Secondary outcomes:
measure: Individual chronotype with the Munich ChronoType Questionnaire
timeFrame: At baseline
measure: Wrist temperature rhythm
timeFrame: At baseline
measure: Rest-activity rhythm
timeFrame: At baseline
measure: Sleeping characteristics with a 7 days dietary record of night time and day time (siesta) information
timeFrame: At baseline
measure: Salivary cortisol determinations
timeFrame: At baseline
measure: Salivary melatonin determinations on weekends the 6th and 7th day of the experimental week
timeFrame: At baseline
measure: Food habits with a 7 days dietary record
timeFrame: At baseline
measure: Total energy intake
timeFrame: At baseline
measure: Macronutrient distribution
timeFrame: At baseline
measure: Food variety
timeFrame: At baseline
measure: Glycemic Index
timeFrame: At baseline
measure: Physical activity
timeFrame: Through study completion
measure: Mediterranean Diet Score
timeFrame: At baseline
measure: Food timing with a 7 days dietary record
timeFrame: At baseline
measure: Light determination
timeFrame: At baseline
measure: DNA collection in saliva
timeFrame: At baseline
measure: Saliva collection for microflora determinations
timeFrame: At baseline
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Chronobiology laboratory, Department of Physiology
city: Murcia
country: Spain
facility: University of Murcia
Study officials:
affiliation: University of Murcia. Spain
name: Marta Garaulet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qian J, Martinez-Lozano N, Tvarijonaviciute A, Rios R, Scheer FAJL, Garaulet M. Blunted rest-activity rhythms link to higher body mass index and inflammatory markers in children. Sleep. 2021 May 14;44(5):zsaa256. doi: 10.1093/sleep/zsaa256.
citation: Barraco GM, Martinez-Lozano N, Vales-Villamarin C, Del Carmen Blaya M, Rios R, Madrid JA, Fardy P, Garaulet M. Circadian health differs between boys and girls as assessed by non-invasive tools in school-aged children. Clin Nutr. 2019 Apr;38(2):774-781. doi: 10.1016/j.clnu.2018.03.001. Epub 2018 Mar 21.