HealthyNCT02883764
Cross-sectional Survey of Omega-3 Fatty Acid Blood Levels
An observational study of Healthy, run by dsm-firmenich Switzerland AG at 1 site in United States.
Trial summary
Employees working at DSM workplaces with an onsite Healthyroads Wellness® biometrics screening program are being offered an opportunity to have their blood fatty acids levels, especially omega-3 fatty acids [omega-3 index] measured at no charge. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 834 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 2 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: DSM offers employees to voluntarily participate in a healthyroads employee wellness program. All DSM employees working at DSM workplaces with an onsite Healthyroads Wellness® biometrics screening program will be informed by email and onsite signs of upcoming Healthyroads wellness clinics. Participants signing up for a Healthyroads Wellness clinic will be invited to participate in an omega-3 research survey.
Who may be able to join
- There are no exclusion criteria. These employees are 18y of age and older.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
DSM Nutritional Products
Parsippany, New Jersey, 07054
About this study
Employees working at DSM workplaces with an onsite Healthyroads Wellness® biometrics screening program are being offered an opportunity to have their blood fatty acids levels, especially omega-3 fatty acids [omega-3 index] measured at no charge. At some locations, participants were offered a single coupon on a 90 day supply of omega-3 capsules. Three months later, all employees at these locations are given a second opportunity to have their blood omega-3 levels [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] measured. The goals are to: 1) survey dietary EPA+DHA intake and omega-3 blood levels of study population, 2) determine if dietary EPA+DHA intake and omega-3 blood levels change after people have learned their omega-3 index, and 3) determine if differences in omega-3 index concentrations can be detected 3 months later between locations receiving information alone vs information+coupon.
Read the detailed description
Email messages and posters announcing onsite HealthyRoads Wellness biometric screening clinics will inform ~1,800 DSM employees at 19 locations of the opportunity to participate in an omega-3 research study and have their blood omega-3 levels measured.
- Participants attending a Healthyroads Wellness® biometrics screening clinic will be invited to participate. If they agree and sign an Informed Consent form, they need to complete an Omega-3 Index Test Request form, and write their name, date of birth and collection date on the filter paper. The request form includes some dietary questions about fish/meat consumption.
- Omega-3 research participants will proceed to the biometric screening station where blood obtained from the finger stick for blood cholesterol measurements will be applied to a filter paper by a Healthyroads Wellness® professional.
- The filter paper, the Omega-3 Index Test Request, and Informed Consent form will be stapled together, packaged with all other samples obtained at that location, and shipped by DSM to a CLIA-approved laboratory.
- Within about a week of receiving the blood sample, the Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory (#43D1105229) will email the Omega-3 Index Test results directly to each participant.
Locations will be randomized such that approximately 50% of participants will receive a coupon for a discount on a 90 day supply of omega-3 capsules. These coupons will be offered to participants in order to determine rates of coupon redemption. If a coupon is offered at a biometrics screening site, a single coupon will be offered to each participant at that location. The coupon will be offered after the finger stick procedure so that it is not an incentive for participation.
Three-four months later, all employees at each location will be offered a second opportunity to have their omega-3 index measured. The filter paper, the Omega-3 Index Test Request, and Informed Consent form will be stapled together, packaged with all other samples obtained at that location, and shipped by DSM to a CLIA-approved laboratory. Based on email address, birthdate, date of collection, and gender, data will be identified as a new participant or second omega-3 index determination. This data will allow for anonymized comparison of first versus second determination of blood omega-3 index measurement to assess the impact of providing participants with information on their omega-3 status vs information + coupon.
- 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 survey of omega-3 fatty acid blood levels
Single fingerstick to know blood levels of omega-3s
Measured: one day
Secondary outcomes (2)
Assessing blood levels of omega-3 fatty acids
Assessment of blood levels of omega-3 fatty acids in people 3 months after learning their omega-3 index
Measured: 3 month followup
Assessing dietary behavior (questionnaire)
Assessing dietary behavior in people 3 months after learning their omega-3 index
Measured: 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startMay 2016
- Primary completion1 Dec 2016
- Study completion2 Dec 2016
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.
- 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
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael I McBurney, PhD, Principal investigator, dsm-firmenich Switzerland AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883764
- Sponsor's protocol ID
- 2016-01-031
- Status last verified
- Feb 2017
- First submitted
- 19 Aug 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 15208005
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Survey of Omega-3 Fatty Acid Blood Levels
- ClinicalTrials.gov ID
- NCT02883764
- Acronym / sponsor ID
- 2016-01-031
- Conditions
- Healthy
- Keywords
- eicosapentaenoic acid, EPA, docosahexaenoic acid, DHA, omega-3 index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 2 Dec 2016 (actual)
- First posted
- 30 Aug 2016 (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.
Employees working at DSM workplaces with an onsite Healthyroads Wellness® biometrics screening program are being offered an opportunity to have their blood fatty acids levels, especially omega-3 fatty acids [omega-3 index] measured at no charge. At some locations, participants were offered a single coupon on a 90 day supply of omega-3 capsules. Three months later, all employees at these locations are given a second opportunity to have their blood omega-3 levels [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] measured. The goals are to: 1) survey dietary EPA+DHA intake and omega-3 blood levels of study population, 2) determine if dietary EPA+DHA intake and omega-3 blood levels change after people have learned their omega-3 index, and 3) determine if differences in omega-3 index concentrations can be detected 3 months later between locations receiving information alone vs information+coupon.
Detailed description
Email messages and posters announcing onsite HealthyRoads Wellness biometric screening clinics will inform ~1,800 DSM employees at 19 locations of the opportunity to participate in an omega-3 research study and have their blood omega-3 levels measured.
- Participants attending a Healthyroads Wellness® biometrics screening clinic will be invited to participate. If they agree and sign an Informed Consent form, they need to complete an Omega-3 Index Test Request form, and write their name, date of birth and collection date on the filter paper. The request form includes some dietary questions about fish/meat consumption.
- Omega-3 research participants will proceed to the biometric screening station where blood obtained from the finger stick for blood cholesterol measurements will be applied to a filter paper by a Healthyroads Wellness® professional.
- The filter paper, the Omega-3 Index Test Request, and Informed Consent form will be stapled together, packaged with all other samples obtained at that location, and shipped by DSM to a CLIA-approved laboratory.
- Within about a week of receiving the blood sample, the Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory (#43D1105229) will email the Omega-3 Index Test results directly to each participant.
Locations will be randomized such that approximately 50% of participants will receive a coupon for a discount on a 90 day supply of omega-3 capsules. These coupons will be offered to participants in order to determine rates of coupon redemption. If a coupon is offered at a biometrics screening site, a single coupon will be offered to each participant at that location. The coupon will be offered after the finger stick procedure so that it is not an incentive for participation.
Three-four months later, all employees at each location will be offered a second opportunity to have their omega-3 index measured. The filter paper, the Omega-3 Index Test Request, and Informed Consent form will be stapled together, packaged with all other samples obtained at that location, and shipped by DSM to a CLIA-approved laboratory. Based on email address, birthdate, date of collection, and gender, data will be identified as a new participant or second omega-3 index determination. This data will allow for anonymized comparison of first versus second determination of blood omega-3 index measurement to assess the impact of providing participants with information on their omega-3 status vs information + coupon.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- DSM offers employees to voluntarily participate in a healthyroads employee wellness program. All DSM employees working at DSM workplaces with an onsite Healthyroads Wellness® biometrics screening program will be informed by email and onsite signs of upcoming Healthyroads wellness clinics. Participants signing up for a Healthyroads Wellness clinic will be invited to participate in an omega-3 research survey.
Key inclusion criteria (1 listed)
- There are no exclusion criteria. These employees are 18y of age and older.
Key exclusion criteria (1 listed)
- None
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 survey of omega-3 fatty acid blood levels
Time frame: one day
Single fingerstick to know blood levels of omega-3s
2 secondary outcomes
Assessing blood levels of omega-3 fatty acids
Time frame: 3 month followup
Assessing dietary behavior (questionnaire)
Time frame: 3 month 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 17 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.
- Individual participant dataSharing planned: Undecided
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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 I McBurney, PhD principal investigator
dsm-firmenich Switzerland AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by dsm-firmenich Switzerland AG at 1 site in United States.
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 17 Feb 2017. 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 United States. 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?
Cross-sectional survey 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 NCT02883764, 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 17 Feb 2017.