- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02895282
Chronobiology and Childhood Obesity in a Mediterranean Spanish Population (ONTIME-JR)
Chronobiology and Childhood Obesity in a Mediterranean Spanish Population (ONTIME-JR: Obesity, Nutrigenomics, Timing, Mediterranean, Junior)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Murcia, Spain, 30100
- University of Murcia
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Murcia, Spain, 30100
- Chronobiology laboratory, Department of Physiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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BMI
Time Frame: At baseline
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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.
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At baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Individual chronotype with the Munich ChronoType Questionnaire
Time Frame: At baseline
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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.
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At baseline
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Wrist temperature rhythm
Time Frame: At baseline
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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.
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At baseline
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Rest-activity rhythm
Time Frame: At baseline
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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.
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At baseline
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Sleeping characteristics with a 7 days dietary record of night time and day time (siesta) information
Time Frame: At baseline
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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.
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At baseline
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Salivary cortisol determinations
Time Frame: At baseline
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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.
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At baseline
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Salivary melatonin determinations on weekends the 6th and 7th day of the experimental week
Time Frame: At baseline
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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.
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At baseline
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Food habits with a 7 days dietary record
Time Frame: At baseline
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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.
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At baseline
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Total energy intake
Time Frame: At baseline
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During the week of the experiment with a software designed for this purpose.
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At baseline
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Macronutrient distribution
Time Frame: At baseline
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from the 7 days dietary record, with a software designed for this purpose.
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At baseline
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Food variety
Time Frame: At baseline
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from the 7 days dietary record, with a software designed for this purpose.
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At baseline
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Glycemic Index
Time Frame: At baseline
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from the 7 days dietary record, with a software designed for this purpose.
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At baseline
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Physical activity
Time Frame: Through study completion
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from the 7 days dietary record, with a software designed for this purpose.
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Through study completion
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Mediterranean Diet Score
Time Frame: At baseline
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From the 7 days dietary record, with a software designed for this purpose.
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At baseline
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Food timing with a 7 days dietary record
Time Frame: At baseline
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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).
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At baseline
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Light determination
Time Frame: At baseline
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During the week of the experiment with a light detector device in the neck of the children.
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At baseline
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DNA collection in saliva
Time Frame: At baseline
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Saliva will be collected to further extraction of DNA the 7th day of the experimental week.
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At baseline
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Saliva collection for microflora determinations
Time Frame: At baseline
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Saliva Collection Method is the SalivaBio Oral Swab the 7th day of the experimental week.
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At baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marta Garaulet, PhD, University of Murcia. Spain
Publications and helpful links
General Publications
- 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). pii: zsaa256. doi: 10.1093/sleep/zsaa256.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAF2014-52480-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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