Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date February 15, 2017
First Posted Date February 17, 2017
Last Update Posted Date February 20, 2017
Actual Study Start Date September 21, 2016
Actual Primary Completion Date September 23, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2017)
Cross-sectional study of omega-3 fatty acid blood levels [ Time Frame: one day ]
Single fingerstick to know blood levels of omega-3s
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 15, 2017)
Assessing dietary intake of omega-3 fatty acids [ Time Frame: one day ]
Self-reported dietary intake
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Health Professional Dietary Habits and Blood Omega-3 Fatty Acid Concentrations
Official Title Health Professional Dietary Habits and Blood Omega-3 Fatty Acid Concentrations
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.
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 Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Health professionals attending the AAFP meeting.
Condition Healthy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 15, 2017)
387
Original Actual Enrollment Same as current
Actual Study Completion Date December 30, 2016
Actual Primary Completion Date September 23, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Registered member of AAFP with permission to visit exhibitor booths

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03056898
Other Study ID Numbers 2016-06-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party DSM Nutritional Products, Inc.
Study Sponsor DSM Nutritional Products, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Michael McBurney, PhD DSM Nutritional Products, Inc.
PRS Account DSM Nutritional Products, Inc.
Verification Date February 2017