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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056898
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

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.

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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

Resource links provided by the National Library of Medicine





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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056898


Sponsors and Collaborators
DSM Nutritional Products, Inc.
Investigators
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Principal Investigator: Michael McBurney, PhD DSM Nutritional Products, Inc.
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT03056898    
Other Study ID Numbers: 2016-06-001
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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