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临床试验/NCT01940679
NCT01940679已完成不适用

Bioavailability of Encapsulated Omega-3 Fatty Acids

United States Army Research Institute of Environmental Medicine2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
2
主要终点
Plasma n-3 concentrations

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • between 18 and 45 years old
  • leave status and have approval from your supervisor (for DoD Civilians)

排除标准

  • 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

结局指标

主要结局

Plasma n-3 concentrations

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

次要结局

未报告次要终点

研究者

发起方
United States Army Research Institute of Environmental Medicine
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Tracey Smith

Research Dietitian

United States Army Research Institute of Environmental Medicine

研究点 (2)

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