Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, 14-049-900, Brazil
NCT Number: NCT01823744
The purpose of this trial is to better define how individuals with different genetic make-ups will require different interventions to improve their methylation potential and nutrient status.
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Notify Me9 year–13 year
All sexes
Interventional
Not applicable
Ribeirão Preto, São Paulo, 14-049-900, Brazil
Despite the increasing incidence of overweight and obesity among children, nutritional deficiencies are still a concern.
A low intake of vitamins and minerals is associated with a reduction in the antioxidant capacity. Some vitamins are associated with chronic diseases including overweight and obesity.
S-adenosylmethionine (SAM) and S-adenosylhomocysteine (SAH) are the substrate and product of essential reactions; the SAM:SAH ratio has been associated with health and is an indicator of cellular DNA methylation potential.
Low level of this ratio may affect short and long term health. In this explorative knowledge building open interventional study, subject to be enrolled are children or adolescents 9 to 13 years of age per year (n=180 per year, over 2 years). The study consists of 6 weeks nutritional intervention followed by a 6 weeks follow up.
In this study, genomics, proteomics, lipidomics analysis will be performed, in addition to biochemistry, hematology and vitamins analysis.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Nestrovit: white chocolate bar with vitamins and minerals
Time frame: baseline and after 6 weeks of product intake
Change from baseline in the correlation between the SAM/SAH ratio in erythrocytes, dietary intakes and, polymorphisms in genes associated with micronutrients
Time frame: baseline, after 6 weeks of product intake and after 6 weeks of follow up
Composite secondary outome: extensive "omic" analysis and correlation of the data over the 3 timepoints
Time frame: after 6 weeks product intake and after 6 weeks of follow up
Change between 6 weeks after product intake and 6 weeks of follow up in the correlation between the SAM/SAH ratio in erythrocytes, dietary intakes and, polymorphisms in genes associated with micronutrients
Société des Produits Nestlé (SPN)
Industry
A New Strategy to Analyze Gene-Nutrient Interaction in Children and Adolescents
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