Plasma Level of Various Omega-3 Lipids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- AUC(0-24h) Plasma OM3
研究概览
简要总结
The primary objective of this study is to evaluate the pharmacokinetic properties of 3 OM3 oils after a single-dose administration in healthy volunteers
详细描述
This is a single center, open design, randomized, controlled, cross-over trial with 3 test periods and 3 products (one test period per product). The three different test periods will be separated by a washout period of at least 6 days (up to 21 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
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
- •Aged between 18 and 65 years old
- •BMI in the normal and overweight range (18.5 to 29.9 kg/m2)
- •Able to understand and to sign written informed consent prior to trial entry
- •Informed consent signed
排除标准
- •Food allergy
- •Documented clinically relevant disease impacting the endpoints of the study or the safety of the subject, as determined by the medical (screening) visit:
- •i. Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc. ii. Known hypertriglyceridemia (on anamnesis) iii. Known Type2 Diabetes Mellitus
- •Under medication that may impact:
- •Dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates (to the opinion of the investigator)
- •Coagulation (blood thinning medications, anticoagulants). Indeed, OM3 have been shown to possibly exert some bleeding by themselves that may increase the bleeding effects of aspirin and anticoagulants
- •Having taken omega-3, EPA/DHA, fish oil supplementation for more than two consecutive weeks during the last 2 months
- •Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
- •Subjects not willing and/or not able to comply with scheduled visits and with the requirements of the study protocol, including trial products consumption and food restriction
- •Pregnancy (on anamnesis)
- •Any direct collaborator of the study leader (Dr. Maurice Beaumont)
- •Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study
研究组 & 干预措施
OM3-FFA
Omega3 linked to free fatty acids
干预措施: OM3-MAG (Dietary Supplement)
OM3-FFA
Omega3 linked to free fatty acids
干预措施: OM3-EE (Dietary Supplement)
OM3 -MAG
Omega3 linked to Monoacylglycerol
干预措施: OM3-FFA (Dietary Supplement)
OM3 -MAG
Omega3 linked to Monoacylglycerol
干预措施: OM3-EE (Dietary Supplement)
OM3-EE
Omega3 linked to ethylester
干预措施: OM3-FFA (Dietary Supplement)
OM3-EE
Omega3 linked to ethylester
干预措施: OM3-MAG (Dietary Supplement)
结局指标
主要结局
AUC(0-24h) Plasma OM3
时间窗: From Time 0 hour to Time 24 hours
Baseline-adjusted total plasma OM3 AUC(0-24h)
次要结局
- Pharmacokinetic parameters (AUC) for EPA and DHA(From Time 0 hour to Time 24 hours)
- Pharmacokinetic parameters (Cmax) for EPA and DHA(From Time 0 hour to Time 24 hours)
- Pharmacokinetic parameters (Tmax) for EPA and DHA(From Time 0 hour to Time 24 hours)