Harmonized Micronutrient Project
|ClinicalTrials.gov Identifier: NCT01823744|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : August 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Genomic||Dietary Supplement: micronutrient supplementation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A New Strategy to Analyze Gene-Nutrient Interaction in Children and Adolescents|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: micronutrient supplementation
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.
Dietary Supplement: micronutrient supplementation
Other Name: Nestrovit: white chocolate bar with vitamins and minerals
- SAM/SAH ratio [ 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
- SNP arrays, proteomics, metabolomics, micronutrient levels [ 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
- SAM/SAH ratio [ 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823744
|Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto|
|Ribeirão Preto, São Paulo, Brazil, 14-049-900|
|Principal Investigator:||Jacqueline Pontes Monteiro, Profa. Dra.||Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto|