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Harmonized Micronutrient Project

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01823744
First Posted: April 4, 2013
Last Update Posted: August 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  Purpose
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.

Condition Intervention
Genomic Dietary Supplement: micronutrient supplementation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A New Strategy to Analyze Gene-Nutrient Interaction in Children and Adolescents

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 146
Study Start Date: March 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Nestrovit: white chocolate bar with vitamins and minerals

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823744


Locations
Brazil
Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14-049-900
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Jacqueline Pontes Monteiro, Profa. Dra. Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
  More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01823744     History of Changes
Other Study ID Numbers: 12.07.NIHS
First Submitted: March 26, 2013
First Posted: April 4, 2013
Last Update Posted: August 5, 2014
Last Verified: August 2014

Keywords provided by Nestlé:
micronutrient
genomic
SAM/SAH ratio

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs