Bioavailability of Encapsulated Omega-3 Fatty Acids

Sponsor
United States Army Research Institute of Environmental Medicine (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01940679
Collaborator
Combat Feeding Directorate at Natick Soldier, Research, Development and Engineering Center (Other)
14
1
4
3
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: encapsulated 600 mg EPA/DHA
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Official Title:
Bioavailability of Encapsulated Omega-3 Fatty Acids
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Plasma n-3 concentrations [15 minute, 2 hrs, 4 hrs and 6 hrs after consumption of n-3 rich food item]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 U.S. Army Research Institute of Environmental Medicine Natick Massachusetts United States 01760

Sponsors and Collaborators

  • United States Army Research Institute of Environmental Medicine
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tracey Smith, Research Dietitian, United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier:
NCT01940679
Other Study ID Numbers:
  • 13-13-H
First Posted:
Sep 12, 2013
Last Update Posted:
Mar 4, 2014
Last Verified:
Mar 1, 2014

Study Results

No Results Posted as of Mar 4, 2014