Bioavailability of Omega-3s in Military RationsNCT01940679
Bioavailability of Encapsulated Omega-3 Fatty Acids
A study testing encapsulated 600 mg EPA/DHA in people with Bioavailability of Omega-3s in Military Rations, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability of Omega-3s in Military Rations
- What is being tested?
- encapsulated 600 mg EPA/DHA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between 18 and 45 years old
- leave status and have approval from your supervisor (for DoD Civilians)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S. Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
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.
- Being tested
- encapsulated 600 mg EPA/DHA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
encapsulated 600 mg EPA/DHADietary supplement
encapsulated 600 mg EPA/DHA
| Study group | Role | What they receive |
|---|---|---|
| Fresh meat stick | Experimental | Fresh meat stick w/ encapsulated 600 mg EPA/DHA; product frozen immediately after production. Receives: Dietary Supplement: encapsulated 600 mg EPA/DHA |
| Stored meat stick | Experimental | Stored meat stick with encapsulated 600 mg EPA/DHA; stored at 100F for 3 months after production Receives: Dietary Supplement: encapsulated 600 mg EPA/DHA |
| Fresh pound cake | Experimental | Fresh pound cake w/ encapsulated 600 mg EPA/DHA; product frozen immediately after production. Receives: Dietary Supplement: encapsulated 600 mg EPA/DHA |
| Stored pound cake | Experimental | Stored pound cake with encapsulated 600 mg EPA/DHA; stored at 100F for 3 months after production. Receives: Dietary Supplement: encapsulated 600 mg EPA/DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma n-3 concentrations
Measured: 15 minute, 2 hrs, 4 hrs and 6 hrs after consumption of n-3 rich food item
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability of Omega-3s in Military RationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- Combat Feeding Directorate at Natick Soldier, Research, Development and Engineering Center
- Responsible party
- Principal investigator, Tracey Smith, United States Army Research Institute of Environmental Medicine
- Investigators
- Tracey J Smith, PhD, Principal investigator, U.S. Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940679
- Sponsor's protocol ID
- 13-13-H
- Status last verified
- Mar 2014
- First submitted
- 9 Sep 2013
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Encapsulated Omega-3 Fatty Acids
- ClinicalTrials.gov ID
- NCT01940679
- Acronym / sponsor ID
- 13-13-H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- Combat Feeding Directorate at Natick Soldier, Research, Development and Engineering Center
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fresh meat stick | Experimental | Dietary Supplement: encapsulated 600 mg EPA/DHAFresh meat stick w/ encapsulated 600 mg EPA/DHA; product frozen immediately after production. |
| Stored meat stick | Experimental | Dietary Supplement: encapsulated 600 mg EPA/DHAStored meat stick with encapsulated 600 mg EPA/DHA; stored at 100F for 3 months after production |
| Fresh pound cake | Experimental | Dietary Supplement: encapsulated 600 mg EPA/DHAFresh pound cake w/ encapsulated 600 mg EPA/DHA; product frozen immediately after production. |
| Stored pound cake | Experimental | Dietary Supplement: encapsulated 600 mg EPA/DHAStored pound cake with encapsulated 600 mg EPA/DHA; stored at 100F for 3 months after production. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- between 18 and 45 years old
- leave status and have approval from your supervisor (for DoD Civilians)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| encapsulated 600 mg EPA/DHAencapsulated 600 mg EPA/DHA | Dietary supplement | Fresh meat stick, Fresh pound cake, Stored meat stick, Stored pound cake |
Primary outcome
Plasma n-3 concentrations
Time frame: 15 minute, 2 hrs, 4 hrs and 6 hrs after consumption of n-3 rich food item
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracey J Smith, PhD principal investigator
U.S. Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing encapsulated 600 mg EPA/DHA in people with Bioavailability of Omega-3s in Military Rations, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma n-3 concentrations (time frame: 15 minute, 2 hrs, 4 hrs and 6 hrs after consumption of n-3 rich food item). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.