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OpenTrials
Completed

NCT Number: NCT01823744

Harmonized Micronutrient Project

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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Key information

Conditions

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ribeirão Preto, São Paulo, 14-049-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

micronutrient supplementation

Dietary Supplement

Other names: Nestrovit: white chocolate bar with vitamins and minerals

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2013
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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