Childhood obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
The study is a clinical nutrition intervention trial. A prospective, randomized, parallel-group, open and multicenter clinical trial will be conducted in 120 male and female children from 6 to 14 year
Sponsors
AZTI
BioCruces Health Research Institute
CNR- ISOF (Consiglio Nazionale delle Ricerche).
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 6 to 14 years 2. With overweight and obesity. Reference will be made to the body mass index (BMI), being defined as overweight when the standard deviation (SD) of the BMI = 2, obesity when DE> 2 and normal weight when -2 <DS = +1 3. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Secondary sources of obesity: malformative syndromes, genetic syndromes accompanied by obesity (Beckwith, Prader-Willi, etc), drug therapies (corticosteroids, psychoactive drugs, etc), hormones alterations of any origin, alterations of the central nervous system (tumors, radiotherapy, surgery, etc) 2. Those with diabetes mellitus (except type 2) 3. Steatosis diagnosis 4. More than 5% weight loss in the 6 months prior to inclusion in the study 5. Allergic processes 6. Hypogonadism or musculoskeletal disorders 7. Transplantation 8. Subjects on antiepileptic, anxiolytic, antipsychotic, or any medication therapy that acts on the central nervous system 9. Patients under antibiotic treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two blood samples of 1 ml and saliva samples are obtained while fasting at baseline and 6 months (visit 3) for the following biochemical measurements: 1. General biochemistry including total cholesterol, triglycerides, HDL - cholesterol, LDL - cholesterol, apolipoprotein A1, apolipoprotein B, SGOT and SGPT, as well as the acute phase inflammatory parameters: uric acid, C-reactive protein and homocysteine 2. Hormonal and Insulin resistance, assessed with HOMA-R levels of glycemia and insulinemia (two determinations of insulin at the beginning, mid-term and end of the study, and IGF-1 and IGF-B-3 will be required) and the interrelation among these hormones implied in the metabolism of the adipose tissue (Leptin, Adipolectin, Ghrelin) 3. Fatty acid profile of the mature erythrocyte membrane and plasma cholesteryl esters, performed in blood samples (1 ml). The samples will be sent to the CNR (Consiglio Nazionale delle Ricerche) in Bologna (Italy) to analyze the lipid profile in mature erythrocyte membrane by GC-MS. (Gas Chromatography Mass Spectrometry) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anthropometric measurements, assessed for each individual following standard protocol by trained personnel. The evaluation of the pubertal stage will performed according to the Tanner's classification for each sex. Body weight, height, and waist circumferences will be measured on the same day of the first interview (at baseline) control visits (3 and 6 months) 2. Blood pressure measured with an automated device: "Critikon Dinamap -8100 "at baseline and 6 months Measured at baseline and control visits (3 and 6 months): 3. Level of physical activity, assessed using the Physical Activity Questionnaire for Children (PAQ-C) 4. Eating behaviours, determined by the validated Dutch Eating Behaviour Questionnaire for Children (DEBQ-C) for use with Spanish children 5. Quality of life, assessed by the KIDSCREEN-10 questionnaire 6. Sleep duration and quality: parents answer the questions of the Spanish version of the Pediatric sleep questionnaire (PSQ) to report on children’s sleep duration and quality 7. Diet quality, recorded by the short Diet Quality Screener (sDQS). Parents answer the questions on their children usual dietary behaviors and Food frequency questionnaire over the previous 12 months 8. Satiety: a subjective assessment will be carried out using a 5-point Likert Scale-based questionnaire “ASTM E2299 - 13 Standard Guide for Sensory Evaluation of Products by Children and Minors” | — |
Countries
Spain
Contacts
Public ContactItziar;Sara Tueros;Arranz Martínez
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Outcome results
None listed