HealthyNCT02296385
Genotype-related Effects of PUFA
A study testing Triple Strength Fish Oil in people with Healthy, run by Société des Produits Nestlé (SPN).
Trial summary
To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements) depending on genotype of relevant factors in lipid metabolism Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Triple Strength Fish Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Aug 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult between 18 and 40 years of age
- BMI between 18.5 and 30 kg/m2
- Sedentary to moderate physical activity habits
Who cannot join
- Concomitant treatment: Consumption of dietary supplements or any medication that can affect the study outcomes
- Actively smoking
- Suspected abuse of alcohol or illicit drugs
- Significant illness within the two weeks prior to study start or any active systemic infection or medical condition that may require treatment during the study
- Known or suspected medical condition related to coagulation
- Subject who cannot be expected to comply with the study procedures
- Currently participating or having participated in another clinical trial during the last 4 weeks prior to beginning of this study
About this study
Official title: Response to PUFA Intervention According to PPAR Genotypes
To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements) depending on genotype of relevant factors in lipid metabolism
Read the detailed description
To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements) depending on genotype of relevant factors in lipid metabolism.
- Conditions
- Healthy
- Being tested
- Triple Strength Fish Oil
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple Strength Fish OilDietary supplement
Triple Strength Fish Oil
| Study group | Role | What they receive |
|---|---|---|
| Supplementation | Experimental | Supplementation Receives: Dietary Supplement: Triple Strength Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in triglyceride levels in plasma
Measured: Baseline and 6 weeks intervention
Secondary outcomes (1)
Assess bioefficacy of EPA and DHA supplementation
The bioefficacy will be evaluated by characterizing and measuring the effects on lipid metabolism, glucose metabolism and insulin resistance, and inflammatory response
Measured: Baseline and 6 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJun 2012
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Elizabeth Tejero Barrera, PhD, Principal investigator, Instituto Nacional de Medicina Genomica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296385
- Sponsor's protocol ID
- 11.16.NRC
- Status last verified
- Nov 2014
- First submitted
- 12 Nov 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Binia A, Vargas-Martinez C, Ancira-Moreno M, Gosoniu LM, Montoliu I, Gamez-Valdez E, Soria-Contreras DC, Angeles-Quezada A, Gonzalez-Alberto R, Fernandez S, Martinez-Conde D, Hernandez-Moran B, Ramirez-Solano M, Perez-Ortega C, Rodriguez-Carmona Y, Castan I, Rubio-Aliaga I, Vadillo-Ortega F, Marquez-Velasco R, Bojalil R, Lopez-Alvarenga JC, Valet P, Kussmann M, Silva-Zolezzi I, Tejero ME. Improvement of cardiometabolic markers after fish oil intervention in young Mexican adults and the role of PPARalpha L162V and PPARgamma2 P12A. J Nutr Biochem. 2017 May;43:98-106. doi: 10.1016/j.jnutbio.2017.02.002. Epub 2017 Feb 10.
PubMed 28282585
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to PUFA Intervention According to PPAR Genotypes
- ClinicalTrials.gov ID
- NCT02296385
- Acronym / sponsor ID
- 11.16.NRC
- Conditions
- Healthy
- Keywords
- volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Nov 2014 (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.
To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements) depending on genotype of relevant factors in lipid metabolism
Detailed description
To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements) depending on genotype of relevant factors in lipid metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supplementation | Experimental | Dietary Supplement: Triple Strength Fish OilSupplementation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult between 18 and 40 years of age
- BMI between 18.5 and 30 kg/m2
- Sedentary to moderate physical activity habits
Key exclusion criteria (7 listed)
- Concomitant treatment: Consumption of dietary supplements or any medication that can affect the study outcomes
- Actively smoking
- Suspected abuse of alcohol or illicit drugs
- Significant illness within the two weeks prior to study start or any active systemic infection or medical condition that may require treatment during the study
- Known or suspected medical condition related to coagulation
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 |
|---|---|---|
| Triple Strength Fish OilTriple Strength Fish Oil | Dietary supplement | Supplementation |
Primary outcome
Changes in triglyceride levels in plasma
Time frame: Baseline and 6 weeks intervention
1 secondary outcome
Assess bioefficacy of EPA and DHA supplementation
Time frame: Baseline and 6 weeks intervention
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 20 Nov 2014.
- Derived from this study: PubMed 28282585Binia A, Vargas-Martinez C, Ancira-Moreno M, Gosoniu LM, Montoliu I, Gamez-Valdez E, Soria-Contreras DC, Angeles-Quezada A, Gonzalez-Alberto R, Fernandez S, Martinez-Conde D, Hernandez-Moran B, Ramirez-Solano M, Perez-Ortega C, Rodriguez-Carmona Y, Castan I, Rubio-Aliaga I, Vadillo-Ortega F, Marquez-Velasco R, Bojalil R, Lopez-Alvarenga JC, Valet P, Kussmann M, Silva-Zolezzi I, Tejero ME. Improvement of cardiometabolic markers after fish oil intervention in young Mexican adults and the role of PPARalpha L162V and PPARgamma2 P12A. J Nutr Biochem. 2017 May;43:98-106. doi: 10.1016/j.jnutbio.2017.02.002. Epub 2017 Feb 10.
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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.
Maria Elizabeth Tejero Barrera, PhD principal investigator
Instituto Nacional de Medicina Genomica
Questions about this trial
What is this clinical trial studying?
A study testing Triple Strength Fish Oil in people with Healthy, run by Société des Produits Nestlé (SPN).
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 7 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 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in triglyceride levels in plasma (time frame: Baseline and 6 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02296385, which also lists 1 linked publication.
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 20 Nov 2014.