Skip to main content
OpenTrials
Completed

NCT Number: NCT01940679

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

U.S. Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

encapsulated 600 mg EPA/DHA

Dietary Supplement

encapsulated 600 mg EPA/DHA

Primary outcomes

  1. Plasma n-3 concentrations

    Time frame: 15 minute, 2 hrs, 4 hrs and 6 hrs after consumption of n-3 rich food item

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Collaborators

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

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 12, 2013
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.