Clinical trial NCT05907785: Biomarkers of Physical Activity/health in Children and Adolescents
Official title: Identification and Validation of Integrative Biomarkers of Physical Activity Level and Health in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Integration analysis
Cardiorespiratory fitness
Metabolomics
Transcriptomics
miRNome
Adipokines
Cytokines
Biomarkers
Lead sponsor: Fundació d'investigació Sanitària de les Illes Balears
Sponsor class: OTHER_GOV
Collaborators: name: Fundación de Investigación Hospital General Universitario de Valencia
name: Czech Academy of Sciences
name: Aix Marseille Université
name: Wageningen University
First posted: 2023-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An educational intervention to improve physical activity and promote healthy dietary habits will be carried out in two groups of children/adolescents: (1) a prepubertal group and (2) a postpubertal group. Within each group, there will be volunteers with normal weight (NW), overweight (OW), and obesity (OB).

A total of 180 volunteers will be assessed for eligibility (90 for each group), and 60 of them (30 for each group) will be allocated to study (intervention study).
Primary purpose: PREVENTION

Brief summary: This clinical trial is aimed to recruit a core cohort of children and adolescents, and to perform an educational intervention and follow-up study in a subgroup of volunteers from this core cohort, to obtain specific measurements and samples of interest in these volunteers that will be used for identification and validation of the biomarkers of physical activity (PA) and health.

Detailed description: Physical activity (PA) provides health benefits across the lifespan and improves many established cardiovascular risk factors that have a significant impact on overall mortality. Childhood and adolescence are critical periods for life-time health; processes underlying cardiovascular diseases and obesity generally originate in early ages. However, it is not clear how PA links to different parameters of health.

There is an important need to cover this critical gap and, more specifically, to have biomarkers allowing to relate the degree of PA with effects on health. INTEGRActiv addresses this new scientific and societal challenge by focusing on the identification of integrated markers reflecting both aspects - PA level and health - in children and adolescents, which represent an important target population to address personalized interventions to improve future, life long, metabolic health. Identification of new biomarkers will be achieved by combining measures of PA and cardiorespiratory and muscular fitness with anthropometric measures, cardiovascular risk factors and endocrine markers, cytokines, circulating miRNA, and gene expression profile in blood cells and metabolomics profile in plasma and blood cells.

Following identification in a core cohort and data integration analysis, candidate biomarkers will be further assessed in core cohort subjects after educational intervention and in existing samples from other independent studies. INTEGRActiv encompasses relevant progress beyond the state-of-the-art for a) the definition of potential biomarkers for PA level in childhood and adolescence; b) the provision of relevant mechanistic information for the link between PA and metabolic health in youth subjects; c) the identification of factors such as age, gender, body weight, sleep behavior and puberal status that quantitatively affect biomarker responses; d) the use and development of new tools in biomarker research, including integrative analysis; e) further assessment and first-step validation of promising candidate biomarkers in an intervention study and other independent studies. It is expected that new identified robust biomarkers reflecting PA level and its relation with health will guide nutritional/life-style and clinical advice and public policies related to endorse biomarker- based personalised PA, with a better adherence and response, to promote health and prevent disease risk factors since early stages of life.

Eligibility criteria: Inclusion Criteria:

* Caucasian children/adolescents with age between 8-10 years for the prepubertal and 13-15 years for the postpubertal groups
* BMI z-score between those established by the World Health Organization for the subgroups with NW, OW or OB

Exclusion Criteria:

* Children/adolescents with reported pathologies
* Clinical recommendations against performance of physical activity
* Presence of eating disorders

Primary outcomes:
measure: BMI Z-score
timeFrame: Baseline (all groups)
measure: BMI Z-score
timeFrame: 3 months (all groups)
measure: BMI Z-score
timeFrame: 6 months (all groups)
Secondary outcomes:
measure: Weight
timeFrame: Baseline (all groups)
measure: Weight
timeFrame: 3 months (all groups)
measure: Weight
timeFrame: 6 months (all groups)
measure: Height
timeFrame: Baseline (all groups)
measure: Height
timeFrame: 3 months (all groups)
measure: Height
timeFrame: 6 months (all groups)
measure: Waist circumference
timeFrame: Baseline (all groups)
measure: Waist circumference
timeFrame: 3 months (all groups)
measure: Waist circumference
timeFrame: 6 months (all groups)
measure: Body composition
timeFrame: Baseline (all groups)
measure: Body composition
timeFrame: 3 months (all groups)
measure: Body composition
timeFrame: 6 months (all groups)
measure: Blood pressure
timeFrame: Baseline (all groups)
measure: Blood pressure
timeFrame: 3 months (all groups)
measure: Blood pressure
timeFrame: 6 months (all groups)
measure: Handgrip strength
timeFrame: Baseline (all groups)
measure: Standing long jump
timeFrame: Baseline (all groups)
measure: Cardiorespiratory Fitness (CRF)
timeFrame: Baseline (all groups)
measure: Change in the level of physical activity (PA) during 6 months evaluated by accelerometry
timeFrame: Change from baseline in physical activity at 6 months (all groups)
measure: Adherence to the Mediterranean diet
timeFrame: Baseline (all groups)
measure: Adherence to the Mediterranean diet
timeFrame: 6 months (all groups)
measure: Physical activity (PA) level
timeFrame: Baseline (all groups)
measure: Physical activity (PA) level
timeFrame: 6 months (all groups)
measure: Sedentary behaviour
timeFrame: Baseline (all groups)
measure: Sedentary behaviour
timeFrame: 6 months (all groups)
measure: Sleep habits
timeFrame: Baseline (all groups)
measure: Sleep habits
timeFrame: 6 months (all groups)
measure: Eating disorders - SCOFF Questionnaire
timeFrame: Baseline (all groups)
measure: Eating disorders - SCOFF Questionnaire
timeFrame: 6 months (all groups)
measure: Eating disorders- DEBQ Questionnaire
timeFrame: Baseline (all groups)
measure: Eating disorders- DEBQ Questionnaire
timeFrame: 6 months (all groups)
measure: Plasma glucose
timeFrame: Baseline (all groups)
measure: Plasma glucose
timeFrame: 6 months (all groups)
measure: Plasma insulin
timeFrame: Baseline (all groups)
measure: Plasma insulin
timeFrame: 6 months (all groups)
measure: Plasma triglycerides (TG)
timeFrame: Baseline (all groups)
measure: Plasma triglycerides (TG)
timeFrame: 6 months (all groups)
measure: Plasma total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)
timeFrame: Baseline (all groups)
measure: Plasma total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)
timeFrame: 6 months (all groups)
measure: Plasma uric acid
timeFrame: Baseline (all groups)
measure: Plasma uric acid
timeFrame: 6 months (all groups)
measure: Plasma creatinine
timeFrame: Baseline (all groups)
measure: Plasma creatinine
timeFrame: 6 months (all groups)
measure: Insulin resistance
timeFrame: Baseline (all groups)
measure: Insulin resistance
timeFrame: 6 months (all groups)
measure: Analysis of additional circulating metabolites
timeFrame: Baseline (all groups)
measure: Analysis of additional circulating metabolites
timeFrame: 6 months (all groups)
measure: Transcriptome analysis
timeFrame: Baseline (all groups)
measure: Transcriptome analysis
timeFrame: 6 months (all groups)
measure: Circulating miRNA
timeFrame: Baseline (all groups)
measure: Circulating miRNA
timeFrame: 6 months(all groups)
measure: Evaluation of metabolomics and lipidomics
timeFrame: Baseline (all groups)
measure: Evaluation of metabolomics and lipidomics
timeFrame: 6 months (all groups)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: General University Hospital Consortium of Valencia
state: Valencian Community
Study officials:
affiliation: Fundació d'investigació Sanitària de les Illes Balears
name: Catalina Picó, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: General University Hospital Consortium of Valencia
name: Empar Lurbe, Prof.
role: PRINCIPAL_INVESTIGATOR
References: