NCT01908374Unknown不适用
A Randomized, Controlled, Crossover Study to Evaluate the Acute and Subchronic Bioavailability of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) From Two Dietary Supplements in Men and Women With Mildly Elevated Triglycerides
Arctic Nutrition AS2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Area under the curve for plasma phosphatidylcholine omega-3 fatty acids
研究概览
简要总结
The primary objective of this study is to test the effects of two different fish oil products containing DHA and EPA by comparing the omega-3 fatty acid levels in the blood.
详细描述
The objective of this study is to evaluate and compare the acute and sub-chronic (2 week) bioavailability of EPA and DHA from two marine oil supplements consumed with a meal in men and women with mildly elevated triglycerides. The supplements provide similar amounts of EPA + DHA esterified as either triglycerides; or esterified as phospholipids and triglycerides.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is male or female, 18-59 years of age, inclusive.
- •Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7).
- •Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3).
- •Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
- •Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL.
- •Subject is willing to refrain from consumption of all fish/seafood (including shellfish), foods rich in choline, fatty acid-containing foods and supplements, and/or EPA-, DHA-containing foods and supplements (≤1.0 g/d ) 14 d prior to visit 2 (day 0) and throughout the study (Appendix 1).
- •Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study.
- •Subject has no plans to change smoking habits during the study period and agrees to abstain from tobacco products for at least 1 h prior to and throughout the duration of the clinic visits [visits 1b, 3 and 5 (days -7, 14 and 56) for up to 2 h; and visits 2 and 4 (days 0 and 42) for up to 14 h].
- •Subject is willing to comply with fecal collection procedures.
- •Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial.
- •Subject understands the study procedures and signs forms providing 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 is male or female, 18-59 years of age, inclusive.
- •Subject has a body mass index (BMI) of ≥18.50 and ≤29.99 kg/m2 at visit 1b (day -7).
- •Subject has a score of 7 to 10 on the Vein Access Scale at visit 1b (day -7; Appendix 3).
- •Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history and routine laboratory test results.
- •Subject has a fasting TG 100-249 mg/dL at visit 1b (day -7). One venous retest allowed if ≥250 mg/dL.
- •Subject is willing to refrain from consumption of all fish/seafood (including shellfish), foods rich in choline, fatty acid-containing foods and supplements, and/or EPA-, DHA-containing foods and supplements (≤1.0 g/d ) 14 d prior to visit 2 (day 0) and throughout the study (Appendix 1).
- •Subject is willing to limit alcohol consumption to no more than 1 drink/d following visit 1b (day -7) and throughout the study.
- •Subject has no plans to change smoking habits during the study period and agrees to abstain from tobacco products for at least 1 h prior to and throughout the duration of the clinic visits [visits 1b, 3 and 5 (days -7, 14 and 56) for up to 2 h; and visits 2 and 4 (days 0 and 42) for up to 14 h].
- •Subject is willing to comply with fecal collection procedures.
- •Subject is willing to maintain habitual diet (with the exception of foods to be restricted), physical activity patterns, and body weight throughout the trial.
- •Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
结局指标
主要结局
Area under the curve for plasma phosphatidylcholine omega-3 fatty acids
时间窗: pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose
The primary outcome variable will be the net incremental area under the curve (niAUC) for plasma phosphatidylcholine (PC) EPA + DHA from pre-meal (t = -0.5 h pre-dose) to 12 h post-dose (niAUC 0-12 h post-dose) measured at visits 2 and 4 (analyzed with and without normalization to the intake of EPA+DHA in each group).
次要结局
- Fasting plasma lipoprotein lipids(pre-dose)
- Product Acceptability Questionnaire(0, 12 hours post-dose)
- Plasma sphingomyelin and total plasma phosphatidylcholine(pre-dose, 0, 1, 2, 4, 6, 8, 10, 12 hours post-dose)
- Area under the curve for plasma phosphatidylcholine omega-3 fatty acids Part 2(pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose)
- Maximum concentration and Time to maximum concentration for plasma omega-3 phosphatidylcholine fatty acids(pre-dose, 1, 2, 4, 6, 8, 10, 12 hours post-dose)
- Gastrointestinal (GI) Tolerability Questionnaire(0, 12 hours post-dose)
- Adverse Events (AE)(pre-treatment, 0, 12 hours post-dose)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)Respiratory Distress Syndrome, AdultAcute Respiratory Distress SyndromeAcute Lung InjuryNCT00351533University of Washington90
已完成
3 期
Efficacy and Safety of a Fish Oil Containing Lipid EmulsionParenteral NutritionNCT01176695B. Braun Melsungen AG240
Unknown
不适用
Study to Evaluate the Effect of a Vegetal Oil on Cognitive ImpairmentCognitive ImpairmentsAlzheimer DiseaseNCT02778581Team Foods Colombia S.A.110
已完成
2 期
The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)HypertriglyceridemiaHIV InfectionsNCT00076518National Institute of Allergy and Infectious Diseases (NIAID)100
已完成
2 期
The Effect of Fish Oils on Human Hepatic Colorectal MetastasesColorectal Liver MetastasesNCT00942292University Hospitals, Leicester20