Investigation of Uptake of Two Different Omega-3 Fatty Acid Products in Healthy Subjects - a Randomized, Two-way Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Comparison of iAUC of EPA+DHA from 0 to 12 hours (iAUC0-12h) between two study products
研究概览
简要总结
The goal of this clinical trial is to compare the uptake of two different omega-3 fatty acid preparations in healthy adults. The main question it aims to answer is whether the two different preparations have the same uptake after single dose supplementation.
详细描述
Participants will be asked to take capsules of the new "phospholipids+" (PL+) omega-3 product (a combination product of krill oil and fish oil) in the morning with a low-fat breakfast. This product contains around 1250 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA).
Researchers will compare this group with another group that takes standard fish oil (FO) ethyl esters (EE, with the same amount of EPA+DHA) to see if there are differences in pharmacokinetic parameters, including incremental area under the curve (iAUC), the maximum concentration of (Cmax) and the time it takes for EPA, DHA and EPA+DHA to reach the maximum concentration (Tmax) in plasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The clinical study will be performed unblinded. However, analysis of blood samples at analysis partner will be performed blinded. After closure of data base, data will be unblinded and evaluated according to product affiliation.
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
- •Healthy males or females (1:1) aged 18 - 65 years
- •Capable and willing to give written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- •Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less
- •No fish consumption at least two weeks prior to screening visit
- •Omega-3 index (≤ 7 %)
- •Non-smoker
- •BMI: 18 to 32 kg/m2
排除标准
- •Omega-3 supplementation history within the last 4 weeks
- •Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases, i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious diseases which could confound the results of the study or put the subject at undue risk
- •Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to baseline
- •Pregnancy, breast feeding or intention to become pregnant during the study (a pregnancy test will be conducted during screening and visits 1-2)
- •General Safety & Laboratory Exclusion Criteria. Patients will be excluded from the study based on the following criteria:
- •Haemoglobin: < 12.0 g/dL (women); < 13.5 g/dL (men)
- •Platelets: < 150 x 103/μL
- •Leukocytes < 4,4 x 103/mm3
- •Aspartate transaminase (AST) or alanine transaminase (ALT) within the normal range
- •Serum creatine within the normal range
- •or further for this study clinically relevant abnormal laboratory findings at screening
- •Significant changes in lifestyle or medication (within last 2 months)
- •Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants (e.g. Marcumar), diuretics, thiazides), which in the investigator's opinion would impact subject safety
- •Difficulty swallowing capsules or predicted inability to swallow the study products
- •Individuals who have made a blood donation in excess of 500 mL or who had excess blood loss within the 4 months before the study starts
- •Individuals who are currently enrolled in an ongoing clinical trial or who have been an active participant in a clinical trial within the last 4 weeks
- •A known allergy or hypersensitivity to any of the ingredients of the study products
- •Not willing to abstain from fish consumption or foods/oils high in omega-3 fatty acids
- •Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
研究组 & 干预措施
Active group
This group will receive a single dose of the PL+ omega 3 fatty acids capsules first, then receive a single dose of the standard FO EE omega 3 fatty acids capsules. Wash-out period is 2 weeks between treatments.
干预措施: PL+ omega 3 fatty acids (Dietary Supplement)
Active group
This group will receive a single dose of the PL+ omega 3 fatty acids capsules first, then receive a single dose of the standard FO EE omega 3 fatty acids capsules. Wash-out period is 2 weeks between treatments.
干预措施: FO EE fatty acids (Dietary Supplement)
Placebo group
This group will receive a single dose of the standard FO EE omega 3 fatty acids capsules first, then receive a single dose of the PL+ omega 3 fatty acids capsules. Wash-out period is 2 weeks between treatments.
干预措施: PL+ omega 3 fatty acids (Dietary Supplement)
Placebo group
This group will receive a single dose of the standard FO EE omega 3 fatty acids capsules first, then receive a single dose of the PL+ omega 3 fatty acids capsules. Wash-out period is 2 weeks between treatments.
干预措施: FO EE fatty acids (Dietary Supplement)
结局指标
主要结局
Comparison of iAUC of EPA+DHA from 0 to 12 hours (iAUC0-12h) between two study products
时间窗: 0h-12h (on Day 1 and Day 15)
Blood concentrations of EPA + DHA in plasma at 0h and 12h will be analyzed, and determination of iAUC0-12h will be calculated. After getting the iAUC0-12h, difference of AUC curves between groups will be calculated. The time point 0h is defined as the time when study subjects is taking the supplement, while time point 12h is defined as 12 hours after the intake of supplement.
次要结局
- Comparison of iAUC DHA from 0 to 12hours (iAUC0-12h) between two study products(0h-12h (on Day 1 and Day 15))
- Comparison of iAUC EPA from 0 to 72hours (iAUC0-72h) between two study products(0h-72h (on Day 4 and Day 18))
- Comparison of iAUC DHA from 0 to 72hours (iAUC0-72h) between two study products(0h-72h (on Day 4 and Day 18))
- Difference on Tmax of EPA+DHA between two products(Day 1 and Day 15)
- Difference on Tmax of DHA between two products(Day 1 and Day 15)
- Comparison of iAUC EPA from 0 to 24hours (iAUC0-24h) between two study products(0h-24h (on Day 2 and Day 16))
- Comparison of iAUC DHA from 0 to 24hours (iAUC0-24h) between two study products(0h-24h (on Day 2 and Day 16))
- Difference on total omega 6 fatty acids vs total omega 3 fatty acid ratio (n-6/n-3) in plasma at 12 hours between two products(Day 1 and Day 15)
- Comparison of iAUC of EPA+DHA from 0 to 24hours (iAUC0-24h) between two study products(0h-24h (on Day 2 and Day 16))
- Comparison of iAUC EPA+DHA from 0 to 72hours (iAUC0-72h) between two study products(0h-72h (on Day 4 and Day 18))
- Comparison of iAUC EPA from 0 to 12hours (iAUC0-12h) between two study products(0h-12h (on Day 1 and Day 15))
- Difference on Cmax of EPA+DHA between two products(Day 1 and Day 15)
- Difference on Cmax of EPA between two products(Day 1 and Day 15)
- Difference on total omega 6 fatty acids vs total omega 3 fatty acid ratio (n-6/n-3) in plasma at 24 hours between two products(Day 2 and Day 16)
- Difference on Cmax of DHA between two products(Day 1 and Day 15)
- Difference on Tmax of EPA between two products(Day 1 and Day 15)
- Difference on total omega 6 fatty acids vs total omega 3 fatty acid ratio (n-6/n-3) in plasma at 72 hours between two products(Day 4 and Day 18)