Clinical trial NCT01940679: Bioavailability of Encapsulated Omega-3 Fatty Acids
Official title: Bioavailability of Encapsulated Omega-3 Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability of Omega-3s in Military Rations
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
Collaborators: name: Combat Feeding Directorate at Natick Soldier, Research, Development and Engineering Center
First posted: 2013-09-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


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

Primary outcomes:
measure: Plasma n-3 concentrations
timeFrame: 15 minute, 2 hrs, 4 hrs and 6 hrs after consumption of n-3 rich food item
Secondary outcomes:
Other outcomes:
Locations:
city: Natick
country: United States
facility: U.S. Army Research Institute of Environmental Medicine
state: Massachusetts
Study officials:
affiliation: U.S. Army Research Institute of Environmental Medicine
name: Tracey J Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: