Harmonized Micronutrient Project

Société des Produits Nestlé (SPN)146 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

146

Conditions

Genomic

Interventions

micronutrient supplementationDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 9 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

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

Time frame: baseline and after 6 weeks of product intake

Secondary Outcomes

SNP arrays, proteomics, metabolomics, micronutrient levels

Composite secondary outome: extensive "omic" analysis and correlation of the data over the 3 timepoints

Time frame: 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

Time frame: after 6 weeks product intake and after 6 weeks of follow up

Data from ClinicalTrials.gov

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