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NCT03056898 Clinical Trial

Health Professional Dietary Habits and Blood Omega-3 Fatty Acid Concentrations

Healthy Clinical Trial

Official title:
Health Professional Dietary Habits and Blood Omega-3 Fatty Acid Concentrations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03056898
Other study ID # 2016-06-001
Secondary ID
Status Completed
Phase N/A
First received February 15, 2017
Last updated February 16, 2017
Start date September 21, 2016
Est. completion date December 30, 2016

Study information
Verified date February 2017
Source DSM Nutritional Products, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 387
Est. completion date December 30, 2016
Est. primary completion date September 23, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Registered member of AAFP with permission to visit exhibitor booths

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
DSM Nutritional Products, Inc.

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cross-sectional study of omega-3 fatty acid blood levels Single fingerstick to know blood levels of omega-3s one day
Secondary Assessing dietary intake of omega-3 fatty acids Self-reported dietary intake one day
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