- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02883764
Cross-sectional Survey of Omega-3 Fatty Acid Blood Levels
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New Jersey
-
Parsippany, New Jersey, United States, 07054
- DSM Nutritional Products
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- There are no exclusion criteria. These employees are 18y of age and older.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cross-sectional survey of omega-3 fatty acid blood levels
Time Frame: one day
|
Single fingerstick to know blood levels of omega-3s
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 month followup
|
Assessing dietary behavior (questionnaire)
Time Frame: 3 month follow up
|
Assessing dietary behavior in people 3 months after learning their omega-3 index
|
3 month follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael I McBurney, PhD, DSM Nutritional Products, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2016-01-031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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