NCT01564160已完成早期 1 期
Assessment of the Acute and Chronic Bioavailability of Marine Lipid Fraction PCSO-524 Relative to a Comparator Product.
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年4月最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Serum Phospholipid
研究概览
简要总结
A marine lipid oil extract isolated from the New Zealand Greenshell® Mussel, Perna canaliculus (P. canaliculus), contains a unique synergistic blend of marine fatty acids.
The objective of the this study is to evaluate the acute (5-hour) and chronic (21-day) bioavailability of a fixed dose of PCSO-524 compared to a fish oil product in a population of healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The individual is fluent in English and understands the study requirements
- •The participant is willing and able to comply with all requirements defined within this protocol.
- •The individual is willing to provide written informed consent
- •The individual is male or female
- •The individual is between 18 and 65 years of age
- •The individual's blood EPA+DPA+DHA ≤ 5.2% at screening
排除标准
- •The individual is unable to or refuses to provide written informed consent
- •The individual has taken omega-3 supplements within 3 months of screening.
- •Supplements containing any of the following sources of omega-3s will exclude the individual from the study: fish oil, flax oil, krill oil, green-lipped mussel, chia, perilla, algea
- •The individual's blood EPA+DPA+DHA ≥ 5.2% at screening
- •The individual is female and pregnant or breastfeeding, or plans to be during the trial period
- •The individual has known allergies product ingredients (fish/seafood)
- •The individual has any significant medical illness or condition
- •The individual has reported a history of drug dependence or substance abuse (excluding nicotine)
- •The individual is taking lipid-altering medications (statins, niacin, carnitine, fibrates etc.)
- •The individual is unable to abstain from caffeine, alcohol or physical activity for 24 hours before each treatment visit
- •The individual will be excluded if he or she has any additional conditions that, in the Investigator's opinion, would preclude the participant from completing the study or would not be in the best interest of the subject. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol
结局指标
主要结局
Serum Phospholipid
时间窗: Day 0 and Day 21
次要结局
- Total Serum Lipid(Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose)
- Serum Free Fatty Acid(Day 21 @ 0 hours, 2 hours, 3 hours, 4 hours and 5 hours post-dose)
研究者
研究点 (2)
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