Healthful Seafood Consumption for Sensitive Populations

This study has been completed.
Sponsor:
Collaborator:
Florida A&M University
Information provided by:
Purdue University
ClinicalTrials.gov Identifier:
NCT01123759
First received: May 12, 2010
Last updated: May 13, 2010
Last verified: May 2010

May 12, 2010
May 13, 2010
January 2008
December 2009   (final data collection date for primary outcome measure)
Hair Mercury [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
The hair mercury after feeding low mercury fish for 3 months
Same as current
Complete list of historical versions of study NCT01123759 on ClinicalTrials.gov Archive Site
  • Blood mercury concentration [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    The blood mercury concentration after feeding low mercury fish for 3 months
  • Blood omega-3 fatty acid concentrations [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Blood omega-3 fatty acid concentration after feeding either salmon or tilapia for 3 months
Same as current
Not Provided
Not Provided
 
Healthful Seafood Consumption for Sensitive Populations
Consuming Fish to Reduce Mercury Intake While Optimizing Omega-3 Fatty Acid Status

Fish can provide pregnant women with omega-3 fatty acids for fetal brain development but some fish contains high levels of mercury which is detrimental to fetal brain development. The hypothesis is that women who have previously consumed high mercury fish can reduce the mercury level in their bodies and improve their omega-3 levels in three months by eating fish that is high in omega-3 fatty acids and low in mercury.

Exposure to methylmercury, a developmental toxicant found primarily in fish. Fish is nutritionally important for providing long chain omega-3 fatty acids that are important for perinatal health. Since maternal transfer of mercury and omega-3 fatty acids are the primary routes for fetal (placental transfer) or infant (maternal milk) exposure, there is a critical need to develop specific advice for childbearing-aged women based upon the 2004 Dietary Guidelines Advisory Committee's recommended intake i.e., consume 8 ounces of fish per week. This clinical trial investigates whether weekly consumption of selected fish species for 12 weeks can improve plasma concentrations of the omega-3 fatty acids (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) while reducing hair or blood mercury concentrations.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Infant Brain Health
Other: Feeding low mercury fish
Subjects fed 6 oz of either tilapia (low omega-3 fish) or salmon (high omega-3 fish) for 3 months. Both fish are low in mercury
  • Active Comparator: Tilapia
    Subjects are fed 6 oz tilapia once a week for 3 months
    Intervention: Other: Feeding low mercury fish
  • Active Comparator: Salmon
    Subjects fed 6 oz salmon once a week for 3 months
    Intervention: Other: Feeding low mercury fish
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hair mercury levels equal to or greater than 0.8 ppm

Exclusion Criteria:

  • Pregnant or planning to become pregnant in the next 3 months
  • Nursing
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01123759
USDA-CSREES 07-5110-03804
No
Charles Santerre, Professor, Purdue University, Dept of Foods and Nutrition
Purdue University
Florida A&M University
Principal Investigator: Charles Santerre, Ph.D Purdue University, Department of Foods and Nutrition
Purdue University
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP