GenomicNCT01823744
Harmonized Micronutrient Project
A study testing micronutrient supplementation in people with Genomic, run by Société des Produits Nestlé (SPN) at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Genomic
- What is being tested?
- micronutrient supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children or adolescents 9 to 13 years of age.
- Clinically stable.
- Normal weight, overweight and obese.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, 14-049-900
About this study
Official title: 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.
Read the 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.
- Conditions
- Genomic
- Being tested
- micronutrient supplementation
- Keywords
- micronutrient, genomic, SAM/SAH ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micronutrient supplementationDietary supplement
Also called Nestrovit: white chocolate bar with vitamins and minerals
| Study group | Role | What they receive |
|---|---|---|
| micronutrient supplementation | Experimental | 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. Receives: Dietary Supplement: micronutrient supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and after 6 weeks of product intake
Secondary outcomes (2)
SNP arrays, proteomics, metabolomics, micronutrient levels
Composite secondary outome: extensive "omic" analysis and correlation of the data over the 3 timepoints
Measured: 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
Measured: after 6 weeks product intake and after 6 weeks of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GenomicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacqueline Pontes Monteiro, Profa. Dra., Principal investigator, Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823744
- Sponsor's protocol ID
- 12.07.NIHS
- Status last verified
- Aug 2014
- First submitted
- 26 Mar 2013
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Strategy to Analyze Gene-Nutrient Interaction in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01823744
- Acronym / sponsor ID
- 12.07.NIHS
- Conditions
- Genomic
- Keywords
- micronutrient, genomic, SAM/SAH ratio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| micronutrient supplementation | Experimental | Dietary Supplement: micronutrient supplementationAll 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. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children or adolescents 9 to 13 years of age.
- Clinically stable.
- Normal weight, overweight and obese.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micronutrient supplementationAlso: Nestrovit: white chocolate bar with vitamins and minerals | Dietary supplement | micronutrient supplementation |
Primary outcome
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
2 secondary outcomes
SNP arrays, proteomics, metabolomics, micronutrient levels
Time frame: baseline, after 6 weeks of product intake and after 6 weeks of follow up
SAM/SAH ratio
Time frame: after 6 weeks product intake and after 6 weeks of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Pontes Monteiro, Profa. Dra. principal investigator
Campus Universitário USP, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micronutrient supplementation in people with Genomic, run by Société des Produits Nestlé (SPN) at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAM/SAH ratio (time frame: baseline and after 6 weeks of product intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.