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.

Study Overview

• Status: Completed
• Conditions: Genomic
• Intervention / Treatment: Dietary supplement: micronutrient supplementation

Detailed Description

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
• Enrollment (Actual): 146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14-049-900
      • Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Nestrovit: white chocolate bar with vitamins and minerals

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Jacqueline Pontes Monteiro, Profa. Dra., Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: March 26, 2013
• First Submitted That Met QC Criteria: March 29, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: genomic; micronutrient; SAM/SAH ratio
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: 12.07.NIHS