## Protocol Section
### Identification Module
**NCT ID:** NCT01940679

**Brief Title:** Bioavailability of Encapsulated Omega-3 Fatty Acids

**Official Title:** Bioavailability of Encapsulated Omega-3 Fatty Acids

#### Organization Study ID Info
**ID:** 13-13-H
#### Organization
**Class:** FED
**Full Name:** United States Army Research Institute of Environmental Medicine
### Status Module
#### Completion Date
**Date:** 2013-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-03-04

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-03-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-12

**Type:** ACTUAL

#### Start Date
**Date:** 2013-09

**Status Verified Date:** 2014-03

#### Study First Post Date
**Date:** 2013-09-12
**Type:** ESTIMATED
**Study First Submit Date:** 2013-09-09
**Study First Submit QC Date:** 2013-09-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Combat Feeding Directorate at Natick Soldier, Research, Development and Engineering Center

#### Lead Sponsor

**Class:** FED

**Name:** United States Army Research Institute of Environmental Medicine

#### Responsible Party

**Investigator Affiliation:** United States Army Research Institute of Environmental Medicine

**Investigator Full Name:** Tracey Smith

**Investigator Title:** Research Dietitian

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Bioavailability of Omega-3s in Military Rations

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

#### Enrollment Info

**Count:** 14

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Fresh meat stick w/ encapsulated 600 mg EPA/DHA; product frozen immediately after production.

**Intervention Names:**

- Dietary Supplement: encapsulated 600 mg EPA/DHA

**Label:** Fresh meat stick

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Stored meat stick with encapsulated 600 mg EPA/DHA; stored at 100F for 3 months after production

**Intervention Names:**

- Dietary Supplement: encapsulated 600 mg EPA/DHA

**Label:** Stored meat stick

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Fresh pound cake w/ encapsulated 600 mg EPA/DHA; product frozen immediately after production.

**Intervention Names:**

- Dietary Supplement: encapsulated 600 mg EPA/DHA

**Label:** Fresh pound cake

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Stored pound cake with encapsulated 600 mg EPA/DHA; stored at 100F for 3 months after production.

**Intervention Names:**

- Dietary Supplement: encapsulated 600 mg EPA/DHA

**Label:** Stored pound cake

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Fresh meat stick

- Fresh pound cake

- Stored meat stick

- Stored pound cake

**Description:** encapsulated 600 mg EPA/DHA

**Name:** encapsulated 600 mg EPA/DHA

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Measure:** Plasma n-3 concentrations

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

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Natick

**Country:** United States

**Facility:** U.S. Army Research Institute of Environmental Medicine

**State:** Massachusetts

**Zip:** 01760

#### Overall Officials

**Official 1:**

**Affiliation:** U.S. Army Research Institute of Environmental Medicine

**Name:** Tracey J Smith, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T415

- Name: Omega 3 Fatty Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
