Harmonized Micronutrient Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A New Strategy to Analyze Gene-Nutrient Interaction in Children and Adolescents

Conditions
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Genomic

Intervention / Treatment
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* Dietary Supplement: micronutrient supplementation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children or adolescents 9 to 13 years of age. Clinically stable. Normal weight, overweight and obese. Exclusion Criteria: Disease diagnosis. At least one episode of axillary temperature >37°C over the prior 15 days. Three or more episodes of liquid or semi-liquid stools over the prior 24 hours. Supplementation with vitamins and/or minerals. On a supervised diet for reducing weight or any other type of diet restriction. Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: micronutrient supplementation<br>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<br> <br> * Other names: Nestrovit: white chocolate bar with vitamins and minerals;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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micronutrient, genomic, SAM/SAH ratio