NCT05438173已完成不适用
A Randomized, Double-Blind, Crossover, Kinetic Study to Assess the Relative Bioavailability of Omega-3 Fatty Acids in Two Supplement Products in Healthy Adult Men and Women
Midwest Center for Metabolic and Cardiovascular Research2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年7月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Baseline-adjusted geometric mean ratio for EPA + DHA AUC
研究概览
简要总结
The objective of this study is to assess the relative bioavailability of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in two supplement products in healthy adult men and women.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18 to 55 y of age, inclusive.
- •Subject has a BMI of 18.50 to 29.99 kg/m
- •Subject has a score ≥7 on the Vein Access Scale.
- •Subject is judged by the Investigator to be in generally good health, on the basis of medical history and screening measurements.
- •Subject is willing and able to undergo the scheduled study procedures.
- •Subject agrees to abstain from consuming more than one meal containing fish per week throughout the study.
- •Subject agrees to abstain from taking fish oil or omega-3 fatty acid supplements throughout the study.
- •Subject is willing to maintain usual physical activity levels for the duration of the study and not to engage in vigorous physical activity for at least 24 h prior to each clinic visit.
- •Subject is willing to abstain from alcohol consumption for at least 24 h prior to each clinic visit.
- •Subject has no plans to change smoking habits during the study.
- •Subject understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
排除标准
- •Subject has consumed more than one meal per week containing fish or seafood within 14 days prior to the first dose of study product (day 0) (washout is permitted).
- •Subject has taken a fish oil or omega-3 fatty acid supplement within 14 days prior to the first dose of study product (day 0) (washout is permitted).
- •Subject has consumed high-dose fish oil ≥1 g/d of EPA + DHA (the sum of EPA and DHA components from prescription or supplement forms) within 3 months prior to visit 2 (day 0).
- •Subject has consumed fish oil (prescription, dietary supplement, and/or EPA and/or DHA enriched foods) within 14 days of visit 2 (day 0).
- •Individual has used prescribed medication or over-the-counter medicinal products, including herbal and dietary supplements (EXCEPT for a daily omega-3 fatty acid-free vitamin and/or mineral supplement or the occasional use of acetaminophen or nonsteroidal anti-inflammatory drugs (such as ibuprofen or naproxen) within 14 days prior to visit 2 (day 0).
- •Subject has a laboratory test result of clinical significance based on the judgment of the Principal Investigator or qualified designee.
- •Subject has a positive result on the urine drug screen.
- •Subject has a clinically significant medical diagnosis that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
- •Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg).
- •Subject has a recent history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
- •Subject has signs or symptoms of an active infection of clinical relevance, or has taken antibiotics, within 14 days prior to any visit (washout is permitted).
- •Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
- •Subject has a known allergy or sensitivity to any ingredients in the study products.
- •Subject has been exposed to any non-registered drug product within 30 days of the first screening visit.
- •Subject has a current or recent history (past 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
- •Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
结局指标
主要结局
Baseline-adjusted geometric mean ratio for EPA + DHA AUC
时间窗: Baseline to 24 hours
Changes in baseline-adjusted geometric mean ratio for EPA + DHA AUC
次要结局
- Unadjusted AUC for EPA, DHA, and EPA + DHA(Baseline to 24 hours)
- Baseline-adjusted maximum concentration for EPA, DHA, and EPA + DHA(Baseline to 24 hours)
- Baseline-adjusted, dose-normalized maximum concentration for EPA, DHA, and EPA + DHA(Baseline to 24 hours)
- Unadjusted maximum concentrations for EPA, DHA, and EPA + DHA(Baseline to 24 hours)
- Baseline-adjusted, dose-normalized AUC for EPA, DHA, and EPA + DHA(Baseline to 24 hours)
- Time to maximum concentration for EPA, DHA, and EPA + DHA(Baseline to 24 hours)
- Baseline-adjusted AUC for EPA and DHA(Baseline to 24 hours)
研究者
研究点 (2)
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