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
  Purpose

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.


Condition Intervention
Infant Brain Health
Other: Feeding low mercury fish

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Consuming Fish to Reduce Mercury Intake While Optimizing Omega-3 Fatty Acid Status

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Hair Mercury [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    The hair mercury after feeding low mercury fish for 3 months


Secondary Outcome Measures:
  • 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


Enrollment: 71
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tilapia
Subjects are fed 6 oz tilapia once a week for 3 months
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: Salmon
Subjects fed 6 oz salmon once a week for 3 months
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123759

Locations
United States, Florida
Florida A&M University
Tallahassee, Florida, United States, 32307-4100
United States, Indiana
Purdue University, Department of Foods and Nutrition
West Lafayette, Indiana, United States, 47907-2059
Sponsors and Collaborators
Purdue University
Florida A&M University
Investigators
Principal Investigator: Charles Santerre, Ph.D Purdue University, Department of Foods and Nutrition
  More Information

No publications provided

Responsible Party: Charles Santerre, Professor, Purdue University, Dept of Foods and Nutrition
ClinicalTrials.gov Identifier: NCT01123759     History of Changes
Other Study ID Numbers: USDA-CSREES 07-5110-03804
Study First Received: May 12, 2010
Last Updated: May 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
Fish
mercury
omega-3 fatty acids
infant
brain development
pregnancy
nursing mother
dietary recommendations
Hair mercury
Blood mercury
Recommendations for pregnant or nursing women
Infant brain health

ClinicalTrials.gov processed this record on August 21, 2014