Chronobiology and Childhood Obesity in a Mediterranean Spanish Population (ONTIME-JR: Obesity, Nutrigenomics, Timing, Mediterranean, Junior)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Universidad de Murcia
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- BMI
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
PROF. MARTA GARAULET AZA
Full professor of University of Murcia
Universidad de Murcia
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
Outcomes
Primary Outcomes
BMI
Time Frame: At baseline
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.
Secondary Outcomes
- Individual chronotype with the Munich ChronoType Questionnaire(At baseline)
- Wrist temperature rhythm(At baseline)
- Rest-activity rhythm(At baseline)
- Sleeping characteristics with a 7 days dietary record of night time and day time (siesta) information(At baseline)
- Food variety(At baseline)
- Glycemic Index(At baseline)
- Physical activity(Through study completion)
- Salivary cortisol determinations(At baseline)
- Salivary melatonin determinations on weekends the 6th and 7th day of the experimental week(At baseline)
- Total energy intake(At baseline)
- Macronutrient distribution(At baseline)
- Food habits with a 7 days dietary record(At baseline)
- Mediterranean Diet Score(At baseline)
- Food timing with a 7 days dietary record(At baseline)
- Light determination(At baseline)
- DNA collection in saliva(At baseline)
- Saliva collection for microflora determinations(At baseline)