CClinicalTrials.gg
CompletedNCT02883764Updated Feb 17, 2017

Cross-sectional Survey of Omega-3 Fatty Acid Blood Levels

An observational study in Healthy, sponsored by DSM Nutritional Products, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-17.

Sponsored by DSM Nutritional Products, Inc. · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
834
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy

Keywords

  • eicosapentaenoic acid
  • EPA
  • docosahexaenoic acid
  • DHA
  • omega-3 index
03

In context

Lead sponsor

DSM Nutritional Products, Inc. is the lead sponsor of 37 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  • There are no exclusion criteria. These employees are 18y of age and older.

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
834 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Cross-sectional survey of omega-3 fatty acid blood levels

    Single fingerstick to know blood levels of omega-3s

    Time frame: one day

Secondary outcomes

  1. 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

    Time frame: 3 month followup

  2. Assessing dietary behavior (questionnaire)

    Assessing dietary behavior in people 3 months after learning their omega-3 index

    Time frame: 3 month follow up

07

Study locations

1 site
  • DSM Nutritional Products
    Parsippany, New Jersey 07054, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02883764
Lead sponsor
DSM Nutritional Products, Inc.
Responsible party
Sponsor
First posted
Aug 30, 2016
Start date
May 2016
Primary completion
Dec 1, 2016
Completion
Dec 2, 2016
Last update
Feb 17, 2017

Study contacts

Michael I McBurney, PhD
principal investigator · DSM Nutritional Products, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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