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Harmonized Micronutrient Project

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ClinicalTrials.gov Identifier: NCT01823744
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
Nestlé

March 26, 2013
April 4, 2013
August 5, 2014
March 2013
June 2014   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01823744 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Harmonized Micronutrient Project
A New Strategy to Analyze Gene-Nutrient Interaction in Children and Adolescents
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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Genomic
Dietary Supplement: micronutrient supplementation
Other Name: Nestrovit: white chocolate bar with vitamins and minerals
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.

Intervention: Dietary Supplement: micronutrient supplementation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
360
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
9 Years to 13 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01823744
12.07.NIHS
Yes
Not Provided
Not Provided
Nestlé
Nestlé
Not Provided
Principal Investigator: Jacqueline Pontes Monteiro, Profa. Dra. Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Nestlé
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP