Bioavailability of Encapsulated Omega-3 Fatty Acids

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.

Study Overview

• Status: Completed
• Conditions: Bioavailability of Omega-3s in Military Rations
• Intervention / Treatment: Dietary supplement: encapsulated 600 mg EPA/DHA

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Natick, Massachusetts, United States, 01760
      • U.S. Army Research Institute of Environmental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fresh meat stick; Fresh meat stick w/ encapsulated 600 mg EPA/DHA; product frozen immediately after production.	Dietary supplement: encapsulated 600 mg EPA/DHA; encapsulated 600 mg EPA/DHA
Experimental: Stored meat stick; Stored meat stick with encapsulated 600 mg EPA/DHA; stored at 100F for 3 months after production	Dietary supplement: encapsulated 600 mg EPA/DHA; encapsulated 600 mg EPA/DHA
Experimental: Fresh pound cake; Fresh pound cake w/ encapsulated 600 mg EPA/DHA; product frozen immediately after production.	Dietary supplement: encapsulated 600 mg EPA/DHA; encapsulated 600 mg EPA/DHA
Experimental: Stored pound cake; Stored pound cake with encapsulated 600 mg EPA/DHA; stored at 100F for 3 months after production.	Dietary supplement: encapsulated 600 mg EPA/DHA; encapsulated 600 mg EPA/DHA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma n-3 concentrations	15 minute, 2 hrs, 4 hrs and 6 hrs after consumption of n-3 rich food item

Collaborators and Investigators

• Sponsor: United States Army Research Institute of Environmental Medicine
• Collaborators: Combat Feeding Directorate at Natick Soldier, Research, Development and Engineering Center
• Investigators: Principal Investigator: Tracey J Smith, PhD, U.S. Army Research Institute of Environmental Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 12, 2013

Study Record Updates

• Last Update Posted (Estimate): March 4, 2014
• Last Update Submitted That Met QC Criteria: March 3, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 13-13-H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No