Healthful Seafood Consumption for Sensitive Populations

Not Applicable

Completed

• Conditions: Infant Brain Health
• Interventions: Other: Feeding low mercury fish

• Registration Number: NCT01123759
• Lead Sponsor: Purdue University

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-05
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-13
• Last Update Submitted: 2010-05-13
• Study First Posted: 2010-05-14
• Last Update Posted: 2010-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tilapia	Feeding low mercury fish	Subjects are fed 6 oz tilapia once a week for 3 months
Salmon	Feeding low mercury fish	Subjects fed 6 oz salmon once a week for 3 months

Primary Outcome Measures

Name	Time	Method
Hair Mercury	3 months	The hair mercury after feeding low mercury fish for 3 months

Secondary Outcome Measures

Name	Time	Method
Blood mercury concentration	3 months	The blood mercury concentration after feeding low mercury fish for 3 months
Blood omega-3 fatty acid concentrations	3 months	Blood omega-3 fatty acid concentration after feeding either salmon or tilapia for 3 months

Trial Locations

Locations (2)

Florida A&M University; 🇺🇸 Tallahassee, Florida, United States

Purdue University, Department of Foods and Nutrition; 🇺🇸 West Lafayette, Indiana, United States