Relative Bioavailability of Different n-3 Fatty Acid Formulations in Humans
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area under concentration time curve (AUC)
研究概览
简要总结
The aim of this study is to examine differences in short term bioavailability between four n-3 FA formulations in healthy males.
详细描述
The long-chain n-3 fatty acids (n-3 FAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are known to positively affect the lipid profile, vascular tone and blood coagulation. Moreover, EPA and DHA possess anti-inflammatory effects and play a central role in the functioning of the brain and central nervous system. Therefore, an increased EPA and DHA intake is highly recommend. However, it is unknown whether different chemical formulations of EPA + DHA rich supplements (re-esterified triglycerides, ethyl-esters, phospholipids) have identical bioavailability. The objective of this study is to examine differences in short term bioavailability between four n-3 FA formulations:
- Supplement 1: EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil uncoated capsules
- Supplement 2: EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (GArTG)
- Supplement 3: EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules
- Supplement 4: DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL)
The study preparations are certificated supplements and available on the market.
There are no comparative investigations, which analyzed the bioavailability of these four n-3 FA formulations in a similar design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •20-50 years,
- •Caucasian,
- •body mass index (BMI) 20-28 kg/m²,
- •no medical treatment,
- •written confirmation of the subjects after detailed spoken and written explanation about the study contents,
- •ability and willingness of the participants to attend the investigator's orders (compliance of the study conditions, consumption of the study drugs according to the dosage commendation
排除标准
- •medical treatment (especially corticosteroids, anti-inflammatory drugs, blood lipids lowering drugs (e.g. statines, fibrates, bile acid exchanger resin, phytosterols)
- •taking any supplements with n-3 FAs, phytosterols, polyglucosamines (Chitosan) or other lipid binding ingredients
- •daily consumption of n-3 FAs rich fish (salmon, mackerel, herring)
- •heavy chronic diseases (tumors, diabetes typ 1, etc.), documented heart disease, documented blood clotting disorders, renal failure, liver diseases
- •documented blood clotting disorders and consumption of coagulation-inhibiting drugs (for example Marcumar, ASS)
- •allergy or intolerance to fish/fish oil or any of the study ingredients of the test products
- •chronic gastro-intestinal diseases (Colitis ulcerosa, Morbus Crohn, pancreatic insufficiency)
- •donation of blood in the last 6 weeks
- •routine consumption of laxative
- •alcohol-, drug- and/or medicament dependence
- •subjects who are not in agreement with the study conditions
- •refusal or rather reset of the consent from the subject
- •active participation in other investigational drug or device trial within the last 30 days
研究组 & 干预措施
Supplement 1
EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil uncoated capsules
干预措施: rTG (Drug)
Supplement 2
EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (GArTG)
干预措施: GArTG (Drug)
Supplement 3
EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules
干预措施: EE (Drug)
Supplement 4
DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL)
干预措施: KPL (Drug)
结局指标
主要结局
Area under concentration time curve (AUC)
时间窗: about 24 hours
Concentration of eicosapentanoiec acid (EPA) and docosahexanoiec acid (DHA) was measured at baseline and after 2, 4, 6, 8 and 24 hours.
次要结局
- Area under concentration time curve (AUC)(about 48 and 72 hours)
研究者
M. Sc. Simone Schmidt
Master of Science
Gottfried Wilhelm Leibniz Universität Hannover