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临床试验/NCT01471366
NCT01471366已完成不适用

What is the Best Way to Take Fish Oil?

University of Mississippi, Oxford1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Adverse Effects

研究概览

简要总结

Many patients complain of fishy breath, upset stomach, or heartburn when taking the recommended amount of fish oil. A common recommendation made by pharmacists is to freeze the fish oil capsules to help decrease adverse gastrointestinal effects. Compliance with over-the-counter (OTC) fish oil is a concern considering the high number of capsules taken daily. The hypothesis of this study is that taking fish oil with milk will help lead to better patient compliance with no difference in adverse effects versus other administration methods.

详细描述

Fish oil has many proposed health benefits such as lowering triglycerides, decreasing inflammation, and reducing risk factors for cardiovascular disease. In order to take the recommended daily dose for hypertriglyceridemia using an OTC fish oil supplement, the daily recommended dose is at least 2 grams (2 capsules) three times a day. The American Heart Association recommends 2-4 grams of omega-3 fatty acid a day to aid in triglyceride reduction. Fish oil is known to cause GI-related adverse effects. Although reported to help, freezing fish oil capsules is inconvenient requiring access to a freezer three times a day. Currently there is a lack of literature to specify the best administration technique or patient compliance data for OTC fish oil supplements. The purpose of this study is to determine an ideal method of taking fish oil. This study will include up to 60 patients that are between the ages of 18-65 years who would be considered generally healthy. Patients will be recruited via e-mails sent to faculty and students of the School of Pharmacy, via flyers in Walgreen's stores, and through word of mouth. The patients will be randomly assigned to one of four treatment groups. Each treatment group will be given 180 capsules and instructed to take two capsules three times a day for thirty days with either food, no food, milk, or frozen. At the end of thirty days, the patient will return the bottle with any remaining pills to the investigator and take a survey. The investigators will assess compliance via pill count.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

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

  • •Patients 18-65 years of age
  • •Minimal medication usage and controlled chronic health conditions

排除标准

  • •Patients with significant renal, hepatic, autoimmune or gastrointestinal tract disease
  • •Patients with uncontrolled chronic health conditions (e.g., diabetes, high blood pressure, high cholesterol or hypothyroidism)
  • •Receiving prescription anti-coagulation, prescription anti-platelet, prescription anti-inflammatory drugs, biologics, chronic steroids, chemotherapy, or otherwise excessive medication regimens
  • •Pregnant/nursing women, <18 years of age, prisoners, or the mentally ill

研究组 & 干预措施

Frozen capsule

Active Comparator

Two frozen fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water without food or dairy products

干预措施: Frozen capsule (Dietary Supplement)

Capsule with food

Active Comparator

Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with food but no dairy products

干预措施: Capsule with food (Dietary Supplement)

Capsule without food

Active Comparator

Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with no food or dairy products

干预措施: Capsule without food (Dietary Supplement)

Capsule with milk

Active Comparator

Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of milk with no food or additional dairy products

干预措施: Capsule with milk (Dietary Supplement)

结局指标

主要结局

Adverse Effects

时间窗: 4 weeks

Subjective survey based patient reported adverse effects

次要结局

  • Compliance(4 weeks)

研究者

发起方
University of Mississippi, Oxford
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Riche

Principal Investigator

University of Mississippi, Oxford

研究点 (1)

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