HealthyNCT03056898
Health Professional Dietary Habits and Blood Omega-3 Fatty Acid Concentrations
An observational study of Healthy, run by dsm-firmenich Switzerland AG.
Trial summary
Health professionals attending the American Association for Family Physicians (AAFP) meeting at the Orlando Convention Center, Sept 21-23, 2016 who visit the DSM Nutritional Products Inc booth will be invited to complete an omega-3 dietary intake survey and have a drop of blood taken by finger stick by a health… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 387 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2016to 30 Dec 2016
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Health professionals attending the AAFP meeting.
Who may be able to join
- Registered member of AAFP with permission to visit exhibitor booths
Who cannot join
- N/A
About this study
Health professionals attending the American Association for Family Physicians (AAFP) meeting at the Orlando Convention Center, Sept 21-23, 2016 who visit the DSM Nutritional Products Inc booth will be invited to complete an omega-3 dietary intake survey and have a drop of blood taken by finger stick by a health professional for blood fatty acid analysis. Dried blood samples on filter paper will be sent to an outside laboratory (OmegaQuant LLC) for analysis. Within 2 weeks, participants will receive an Omega-3 Index Test report by email from OmegaQuant LLC. After removing personal information, OmegaQuant LLC will share blood fatty acid and omega-3 dietary intake results with the sponsor.
Read the detailed description
Omega-3s are important for heart, brain, and joint health. Most Americans have low levels of omega-3s, especially the long-chain fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in their blood. The only way to know blood levels of omega-3s is by measurement. The Omega-3 index, a measure of EPA+DHA levels in blood, is determined in a single drop of blood obtained from a finger stick. Blood levels of EPA+DHA can be improved by simple dietary changes.
Twenty-two percent of family physicians report knowing their Omega-3 Index. DSM Nutritional Products Inc will announce the "Know Your O" program at the American Association for Family Physicians (AAFP) meeting at the Orlando Convention Center, Orlando FL, Sept 21-23, 2016 and encourage health professionals to visit the DSM booth (#616) and participate in a dietary survey and have their blood fatty acids measured. After learning more about the study at the DSM Nutritional Products Inc booth, participants will sign an Informed Consent Form, complete an Omega-3 Index Test Request form, and write their name, date of birth and collection date on an OmegaQuant LLC filter paper. Participants will then have a finger stick by a representative from InHouse Physicians, 333 N. Randall Road, Suite 140, St. Charles, IL 60174. Tel (630) 244-0887. Website: www.inhousephysicians.com. The Omega-3 Index Test Request, Informed Consent form and Filter Paper with dried blood sample will be stapled together, packaged with all other samples obtained at that location, and shipped by DSM Nutritional Products Inc to OmegaQuant LLC. Within 2 weeks of receiving the blood sample, OmegaQuant LLC will email the Omega-3 Test results directly to each participant. After removing personal information, OmegaQuant LLC will share blood fatty acid and omega-3 dietary intake results with DSM Nutritional Products Inc for statistical and reporting purposes. DSM Nutritional Products Inc will be unable to link data to any individual. There are no other obligations for participants.
- Conditions
- Healthy
- Keywords
- eicosapentaenoic acid, EPA, docosahexaenoic acid, DHA, omega-3 index
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional study of omega-3 fatty acid blood levels
Single fingerstick to know blood levels of omega-3s
Measured: one day
Secondary outcomes (1)
Assessing dietary intake of omega-3 fatty acids
Self-reported dietary intake
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start21 Sep 2016
- Primary completion23 Sep 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael McBurney, PhD, Principal investigator, dsm-firmenich Switzerland AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056898
- Sponsor's protocol ID
- 2016-06-001
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harris WS, Von Schacky C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Prev Med. 2004 Jul;39(1):212-20. doi: 10.1016/j.ypmed.2004.02.030.
PubMed 15208005Matusheski NV, Marshall K, Hartunian-Sowa S, McBurney MI. US Family Physicians Overestimate Personal omega-3 Fatty Acid Biomarker Status: Associations with Fatty Fish and omega-3 Supplement Intake. Curr Dev Nutr. 2017 Dec 7;2(2):nzx007. doi: 10.3945/cdn.117.002188. eCollection 2018 Feb.
PubMed 30377677
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Professional Dietary Habits and Blood Omega-3 Fatty Acid Concentrations
- ClinicalTrials.gov ID
- NCT03056898
- Acronym / sponsor ID
- 2016-06-001
- Conditions
- Healthy
- Keywords
- eicosapentaenoic acid, EPA, docosahexaenoic acid, DHA, omega-3 index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 23 Sep 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 17 Feb 2017 (actual)
- 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.
Health professionals attending the American Association for Family Physicians (AAFP) meeting at the Orlando Convention Center, Sept 21-23, 2016 who visit the DSM Nutritional Products Inc booth will be invited to complete an omega-3 dietary intake survey and have a drop of blood taken by finger stick by a health professional for blood fatty acid analysis. Dried blood samples on filter paper will be sent to an outside laboratory (OmegaQuant LLC) for analysis. Within 2 weeks, participants will receive an Omega-3 Index Test report by email from OmegaQuant LLC. After removing personal information, OmegaQuant LLC will share blood fatty acid and omega-3 dietary intake results with the sponsor.
Detailed description
Omega-3s are important for heart, brain, and joint health. Most Americans have low levels of omega-3s, especially the long-chain fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in their blood. The only way to know blood levels of omega-3s is by measurement. The Omega-3 index, a measure of EPA+DHA levels in blood, is determined in a single drop of blood obtained from a finger stick. Blood levels of EPA+DHA can be improved by simple dietary changes.
Twenty-two percent of family physicians report knowing their Omega-3 Index. DSM Nutritional Products Inc will announce the "Know Your O" program at the American Association for Family Physicians (AAFP) meeting at the Orlando Convention Center, Orlando FL, Sept 21-23, 2016 and encourage health professionals to visit the DSM booth (#616) and participate in a dietary survey and have their blood fatty acids measured. After learning more about the study at the DSM Nutritional Products Inc booth, participants will sign an Informed Consent Form, complete an Omega-3 Index Test Request form, and write their name, date of birth and collection date on an OmegaQuant LLC filter paper. Participants will then have a finger stick by a representative from InHouse Physicians, 333 N. Randall Road, Suite 140, St. Charles, IL 60174. Tel (630) 244-0887. Website: www.inhousephysicians.com. The Omega-3 Index Test Request, Informed Consent form and Filter Paper with dried blood sample will be stapled together, packaged with all other samples obtained at that location, and shipped by DSM Nutritional Products Inc to OmegaQuant LLC. Within 2 weeks of receiving the blood sample, OmegaQuant LLC will email the Omega-3 Test results directly to each participant. After removing personal information, OmegaQuant LLC will share blood fatty acid and omega-3 dietary intake results with DSM Nutritional Products Inc for statistical and reporting purposes. DSM Nutritional Products Inc will be unable to link data to any individual. There are no other obligations for participants.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Health professionals attending the AAFP meeting.
Key inclusion criteria (1 listed)
- Registered member of AAFP with permission to visit exhibitor booths
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cross-sectional study of omega-3 fatty acid blood levels
Time frame: one day
Single fingerstick to know blood levels of omega-3s
1 secondary outcome
Assessing dietary intake of omega-3 fatty acids
Time frame: one day
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 Feb 2017.
- Results publication: PubMed 15208005Harris WS, Von Schacky C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Prev Med. 2004 Jul;39(1):212-20. doi: 10.1016/j.ypmed.2004.02.030.
- Derived from this study: PubMed 30377677Matusheski NV, Marshall K, Hartunian-Sowa S, McBurney MI. US Family Physicians Overestimate Personal omega-3 Fatty Acid Biomarker Status: Associations with Fatty Fish and omega-3 Supplement Intake. Curr Dev Nutr. 2017 Dec 7;2(2):nzx007. doi: 10.3945/cdn.117.002188. eCollection 2018 Feb.
- Individual participant dataSharing planned: No
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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.
Michael McBurney, PhD principal investigator
dsm-firmenich Switzerland AG
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by dsm-firmenich Switzerland AG.
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 1 inclusion and 1 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 Feb 2017. 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?
Cross-sectional study of omega-3 fatty acid blood levels (time frame: one day). 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 NCT03056898, which also lists 2 linked publications.
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 Feb 2017.