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

• ClinicalTrials.gov Identifier: NCT03056898
• Recruitment Status: Completed
• First Posted: February 17, 2017
• Last Update Posted: February 20, 2017
• Sponsor: DSM Nutritional Products, Inc.
• Information provided by (Responsible Party): DSM Nutritional Products, Inc.

Study Description

Brief 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.

Condition or disease
Healthy

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 387 participants
• Observational Model: Ecologic or Community
• Time Perspective: Cross-Sectional
• Official Title: Health Professional Dietary Habits and Blood Omega-3 Fatty Acid Concentrations
• Actual Study Start Date: September 21, 2016
• Actual Primary Completion Date: September 23, 2016
• Actual Study Completion Date: December 30, 2016

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Cross-sectional study of omega-3 fatty acid blood levels [ Time Frame: one day ]
   Single fingerstick to know blood levels of omega-3s

Secondary Outcome Measures :

1. Assessing dietary intake of omega-3 fatty acids [ Time Frame: one day ]
   Self-reported dietary intake

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Health professionals attending the AAFP meeting.

Criteria

Inclusion Criteria:

• Registered member of AAFP with permission to visit exhibitor booths

Exclusion Criteria:

• N/A

Contacts and Locations

Sponsors and Collaborators

DSM Nutritional Products, Inc.

Investigators

• Principal Investigator: Michael McBurney, PhD; DSM Nutritional Products, Inc.

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Matusheski NV, Marshall K, Hartunian-Sowa S, McBurney MI. US Family Physicians Overestimate Personal ω-3 Fatty Acid Biomarker Status: Associations with Fatty Fish and ω-3 Supplement Intake. Curr Dev Nutr. 2017 Dec 7;2(2):nzx007. doi: 10.3945/cdn.117.002188. eCollection 2018 Feb.

• Responsible Party: DSM Nutritional Products, Inc.
• ClinicalTrials.gov Identifier: NCT03056898
• Other Study ID Numbers: 2016-06-001
• First Posted: February 17, 2017
• Last Update Posted: February 20, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DSM Nutritional Products, Inc.:

eicosapentaenoic acid; EPA; docosahexaenoic acid; DHA; omega-3 index