A New Strategy to Analyze Gene-Nutrient Interaction in Children and Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- SAM/SAH ratio
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 9 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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: micronutrient supplementation (Dietary Supplement)
Outcomes
Primary Outcomes
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 Outcomes
- SNP arrays, proteomics, metabolomics, micronutrient levels(baseline, after 6 weeks of product intake and after 6 weeks of follow up)
- SAM/SAH ratio(after 6 weeks product intake and after 6 weeks of follow up)