Healthful Seafood Consumption for Sensitive Populations

NCT ID: NCT01123759

Last Updated: 2010-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-12-31

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.

Conditions

Infant Brain Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tilapia

Subjects are fed 6 oz tilapia once a week for 3 months

Group Type: ACTIVE_COMPARATOR

Feeding low mercury fish

Intervention Type: 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

Salmon

Subjects fed 6 oz salmon once a week for 3 months

Group Type: ACTIVE_COMPARATOR

Feeding low mercury fish

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Florida A&M University

OTHER

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Purdue University, Dept of Foods and Nutrition

Principal Investigators

Charles Santerre, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Purdue University, Department of Foods and Nutrition

Locations

Florida A&M University

Tallahassee, Florida, United States

Purdue University, Department of Foods and Nutrition

West Lafayette, Indiana, United States

Countries

United States

Other Identifiers

USDA-CSREES 07-5110-03804

Identifier Type: -

Identifier Source: org_study_id