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OpenTrials
Completed

NCT Number: NCT02883764

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

DSM Nutritional Products

Parsippany, New Jersey, 07054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

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

    Time frame: one day

    Single fingerstick to know blood levels of omega-3s

Secondary outcomes

  1. Assessing blood levels of omega-3 fatty acids

    Time frame: 3 month followup

    Assessment of blood levels of omega-3 fatty acids in people 3 months after learning their omega-3 index

  2. Assessing dietary behavior (questionnaire)

    Time frame: 3 month follow up

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

Sponsors and collaborators

Lead sponsor

dsm-firmenich Switzerland AG

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 30, 2016
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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