Healthful Seafood Consumption for Sensitive Populations

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Infant Brain Health

Intervention / Treatment
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* Other: Feeding low mercury fish


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tilapia<br>Subjects are fed 6 oz tilapia once a week for 3 months | Other: Feeding low mercury fish<br>* 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<br>|
| Active Comparator: Salmon<br>Subjects fed 6 oz salmon once a week for 3 months | Other: Feeding low mercury fish<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair Mercury | The hair mercury after feeding low mercury fish for 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood mercury concentration | The blood mercury concentration after feeding low mercury fish for 3 months | 3 months | 
| Blood omega-3 fatty acid concentrations | Blood omega-3 fatty acid concentration after feeding either salmon or tilapia for 3 months | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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