Correlation Between Level of Polyunsaturated Fatty Acid EPA and DHA in Blood After Digestion of ProBios Omega-3 Concordix™ Compared With Omega-3 Soft Capsules - a Pilot
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- The incremental (change from baseline) area under the blood plasma concentration curve of Vitamin E
研究概览
简要总结
The purpose of this study is to compare the short term absorption of EPA and DHA from triglycerides (TG) released from normal soft gel capsules and from the new patent pending vehicle providing a gastric stable emulsion.
详细描述
The present study comprises the design of as well as the effect of pre-emulsification of ω-3 fatty acids on the bioavailability of docosahexaenoic acid and eicosapentaenoic acid. In-vitro studies have shown that long-term steric stabilization of an o/w-emulsion is obtained by arresting the oil droplets in a gelatin continuous gel matrix. The emulsion was also stable upon dissolution of the gel matrix at physiological conditions in-vitro and is hence referred to as a gastric stable emulsion (GSE).
In the bioavailability study, healthy young students were recruited and presented two different single-dose treatments of fish oil containing 5 grams of ω-3 fatty acids; one group receiving the fatty acids in traditional soft gel capsules, whereas the other group received the fatty acids using the GSE technology. Time resolved (2 - 26 hours) blood plasma analysis after intake of this single dose ω-3 fatty acids revealed significantly increased AUC0-26h and Cmax of EPA and EPA + DHA when administered as GSE compared to traditional soft gel capsules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Student at Nord-Trondelag University College
- •Healthy (no known condition)
- •Males and females aged 19 to 29 years
排除标准
- •Fish allergies
- •Ongoing consumption of omega-3 fatty acids
- •Subjects receiving anticoagulation or non-steroid anti-inflammatory treatment
- •Subjects with a known metabolic syndrome; diabetes, hypercholesterol, hypertension, obesity
结局指标
主要结局
The incremental (change from baseline) area under the blood plasma concentration curve of Vitamin E
时间窗: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The incremental (change from baseline) area under the blood plasma concentration curve of eicosapentaenoic acid (EPA)
时间窗: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
The incremental (change from baseline) area under the blood plasma concentration curve of docosahexaenoic acid (DHA)
时间窗: 26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration)
次要结局
- The maximal incremental blood plasma concentration of EPA(26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration))
- The maximal incremental blood plasma concentration of DHA(26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration))
- The maximal incremental blood plasma concentration of Vitamin E(26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration))
- The time passed since administration at which the incremental plasma concentration maximum occurs for EPA(26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration))
- The time passed since administration at which the incremental plasma concentration maximum occurs for DHA(26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration))
- The time passed since administration at which the incremental plasma concentration maximum occurs for Vitamin E(26 hours (blood samples taken at baseline and 2, 3, 4, 6, 8 and 26 hours after treatment administration))