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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| micronutrient supplementation | Experimental | All the enrolled subjects will recieve orally, onca a day, during school days a chocolate bar including vitamins and minerals. The micronitrient supplementation will be consumed over 6 weeks, 5 days/week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micronutrient supplementation | Dietary Supplement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| SAM/SAH ratio | Change from baseline in the correlation between the SAM/SAH ratio in erythrocytes, dietary intakes and, polymorphisms in genes associated with micronutrients | baseline and after 6 weeks of product intake |
| Measure | Description | Time Frame |
|---|---|---|
| SNP arrays, proteomics, metabolomics, micronutrient levels | Composite secondary outome: extensive "omic" analysis and correlation of the data over the 3 timepoints | baseline, after 6 weeks of product intake and after 6 weeks of follow up |
| SAM/SAH ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Pontes Monteiro, Profa. Dra. | Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | Ribeirão Preto | São Paulo | 14-049-900 | Brazil |
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| ID | Term |
|---|---|
| D014815 | Vitamins |
| D008903 | Minerals |
| ID | Term |
|---|---|
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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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 |
| after 6 weeks product intake and after 6 weeks of follow up |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D007287 | Inorganic Chemicals |