Harmonized Micronutrient Project

Not Applicable

Completed

• Conditions: Genomic
• Interventions: Dietary Supplement: micronutrient supplementation

• Registration Number: NCT01823744
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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.

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-03-29
• Study First Posted: 2013-04-04
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
micronutrient supplementation	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.

Primary Outcome Measures

Name	Time	Method
SAM/SAH ratio	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 Outcome Measures

Name	Time	Method
SNP arrays, proteomics, metabolomics, micronutrient levels	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	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

Trial Locations

Locations (1)

Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; 🇧🇷 Ribeirão Preto, São Paulo, Brazil