Harmonized Micronutrient Project

Genomic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823744
• Other study ID #: 12.07.NIHS
• Status: Completed
• Phase: N/A
• First received: March 26, 2013
• Last updated: August 4, 2014
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: CONEP: Comissão Nacional de Ética em Pesquisa
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 13 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Genomic

Intervention

Dietary Supplement:
• micronutrient supplementation

Locations

Country	Name	City	State
Brazil	Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No