Bioavailability of Encapsulated Omega-3 Fatty Acids

NCT ID: NCT01940679

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-12-31

Brief Summary

Omega-3 fatty acids (n-3s), particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have anti-inflammatory properties and other documented beneficial health effects that could warrant n-3 fortification of combat rations. However, military combat rations must meet rigorous shelf-stability guidelines (e.g.,, 3 years at 80°F or 6 months at 100°F), which is problematic for natural food sources of n-3s (e.g., oil and fish), which degrade when exposed to high temperatures and prolonged shelf-storage. Encapsulation, e.g., coating freeze dried n-3s with gelatin, can prevent this degradation, and Natick Soldier Research, Development and Engineering Center's (NSRDEC) Combat Feeding Directorate used encapsulated n-3 technology to produce n-3 enriched ration items that withstand environmental stressors and meet shelf-life specifications for military rations. However, the bioavailability of the encapsulated n-3s in these rations is unknown, particularly when they are incorporated into high-protein food items and exposed to high temperatures and prolonged storage. In this randomized, cross-over study, civilian and/or military personnel will be asked to consume: 1) a high protein food item enriched with encapsulated n-3s (600 mg) and previously stored for 6 months at 100°F; 2) a low-protein food item enriched with encapsulated n-3s (600 mg) and previously stored for 6 months at 100°F; 3) a high protein food item with encapsulated n-3s (600 mg) that was not subjected to high-temperature and prolonged storage; and, 4) a low-protein food item with encapsulated n-3s (600 mg) that was not subjected to high temperature and prolonged storage. Serial blood sampling to measure acute changes in the circulating fatty acid profile will occur in the hour before and 6 hours after consumption of each ration component. The only known risks, which this study presents to participants, are those associated with venous catheter placement. The results will help military ration developers determine the ration components best suited for n-3 fortification.

Conditions

Bioavailability of Omega-3s in Military Rations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: TRIPLE

Study Groups

Fresh meat stick

Fresh meat stick w/ encapsulated 600 mg EPA/DHA; product frozen immediately after production.

Group Type: EXPERIMENTAL

encapsulated 600 mg EPA/DHA

Intervention Type: DIETARY_SUPPLEMENT

encapsulated 600 mg EPA/DHA

Stored meat stick

Stored meat stick with encapsulated 600 mg EPA/DHA; stored at 100F for 3 months after production

Group Type: EXPERIMENTAL

encapsulated 600 mg EPA/DHA

Intervention Type: DIETARY_SUPPLEMENT

encapsulated 600 mg EPA/DHA

Fresh pound cake

Fresh pound cake w/ encapsulated 600 mg EPA/DHA; product frozen immediately after production.

Group Type: EXPERIMENTAL

encapsulated 600 mg EPA/DHA

Intervention Type: DIETARY_SUPPLEMENT

encapsulated 600 mg EPA/DHA

Stored pound cake

Stored pound cake with encapsulated 600 mg EPA/DHA; stored at 100F for 3 months after production.

Group Type: EXPERIMENTAL

encapsulated 600 mg EPA/DHA

Intervention Type: DIETARY_SUPPLEMENT

encapsulated 600 mg EPA/DHA

Interventions

encapsulated 600 mg EPA/DHA

encapsulated 600 mg EPA/DHA

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• between 18 and 45 years old
• leave status and have approval from your supervisor (for DoD Civilians)

Exclusion Criteria

• under the age of 18 or over the age of 45
• bleeding disorder (von Willebrand disease, hemophilia) or taking medications that impair ability to stop bleeding (heparin)
• consumed ≥1 serving (equivalent to a deck of cards) of salmon, herring, mackerel, anchovies, sardines, halibut or tuna or omega-3 enriched eggs per week over the previous past month
• regularly consume dietary supplements (for example, capsules) containing omega-3 fatty acids

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Combat Feeding Directorate at Natick Soldier, Research, Development and Engineering Center

UNKNOWN

Sponsor Role: collaborator

United States Army Research Institute of Environmental Medicine

FED

Sponsor Role: lead

Responsible Party

Tracey Smith

Research Dietitian

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracey J Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

U.S. Army Research Institute of Environmental Medicine

Locations

U.S. Army Research Institute of Environmental Medicine

Natick, Massachusetts, United States

Countries

United States

Other Identifiers

13-13-H

Identifier Type: -

Identifier Source: org_study_id