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OpenTrials
Completed

NCT Number: NCT01123759

Healthful Seafood Consumption for Sensitive Populations

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.

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Key information

Conditions

Infant Brain Health

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Florida A&M University, Tallahassee, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feeding low mercury fish

Other

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

Primary outcomes

  1. Hair Mercury

    Time frame: 3 months

    The hair mercury after feeding low mercury fish for 3 months

Secondary outcomes

  1. Blood mercury concentration

    Time frame: 3 months

    The blood mercury concentration after feeding low mercury fish for 3 months

  2. Blood omega-3 fatty acid concentrations

    Time frame: 3 months

    Blood omega-3 fatty acid concentration after feeding either salmon or tilapia for 3 months

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Florida A&M University

Registry information

Official study title

Consuming Fish to Reduce Mercury Intake While Optimizing Omega-3 Fatty Acid Status

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 14, 2010
Registry last updated
May 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.