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临床试验/NCT04382027
NCT04382027已完成不适用

Comparison of Pharmacokinetics of Omega-3 Fatty Acid Supplements in Monoacylglycerol or Ethyl Ester in Humans: a Randomized Controlled Trial.

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
The bioavailability of EPA and DHA in the plasma

研究概览

简要总结

North American diets have insufficient omega-3 fatty acid (n-3 FA) content. Consequently, they display low plasma concentrations of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the two main long chain n-3 FA. A quick and easy way to increase the level of dietary n-3 FA is to take supplements. However, people report side effects in using the currently available supplements, such as gastrointestinal discomfort, nausea and gastric reflux; especially those where EPA and DHA are esterified as ethyl esters (EE). Moreover, EE supplements are less absorbed compared to other esterification forms, such as mono-, di- or triglycerides. The objective of this study was to test the pharmacokinetics of a new n-3 FA supplementation formulation rich in FAs esterified as monoacylglyceride (MAG).

详细描述

The growing presence on the North American as well as European market of food products enriched with fish oil as a source of polyunsaturated fatty acids (PUFA) omega-3 in the diet requires evaluation and comment. Research exploring health influence of the consumption of fish oil started in 1990 years. It was established that long-chain omega-3 PUFA (EPA C20:5 and DHA C22:6) has beneficial effect on human health. Fish oil is the main dietary source of long-chain omega-3 PUFA. Dietary recommendations suggest that the consumption of omega-3 PUFA should increase. The European Academy of Nutritional Sciences (EANS) and the United Kingdom dietary guidelines recommend a daily average intake of 0.2g of EPA plus DHA. In 2000, the Food and Drug Administration stated that the daily intake of EPA and DHA should increase up to 3.0 g per person in the form of fish oil, from food and dietary supplements. According to the World Health Organization recommendations for preventing cardiovascular diseases, one portion of fish should provide an equivalent of 200-500 mg of EPA and DHA. Due to the low fish consumption in developed societies, it seems reasonable to introduce fish oil in capsule supplement dosage forms and several food products enriched with fish oil that can be an additional source of the desirable long-chain omega-3 PUFA in the diet. For this purpose, reaching the recommended daily intake may require taking several capsules of fish oil per day.

Several studies have been performed to evaluate the potential health benefits brought by the consumption of food enriched with fish oil. Some studies suggest that different amounts of long-chain omega-3 - DHA and EPA, provided in a supplement form or added to food products, result in the same effect in changes in the blood lipid profile. The development of fish oil enriched food must be based on the scientific knowledge of the target function in the body and show that the effects are relevant for improved health or reduction of disease risk. The physiological effects of the intake of omega-3 fatty acids added to foods may differ depending on the quality of the fish oil used and the type of product.

Fish oil benefits range from decreasing risk of the so-called life-style diseases, particularly cardiovascular diseases, to combating depression, bipolar disorder and schizophrenia. Fish oil has also prophylaxis effects and treatment effects on inflammation, arthritis, anti-aging, age-related macular degeneration and mental health. Most of dietary lipids ingested from food consist of triacyglycerols. Prior to passive diffusion into the enterocytes, lipid digestion and emulsification are initiated by the action of different lipases resulting in the release of 2 free fatty acids and one monoglyceride-linked fatty acid. They are incorporated into mixed micelles to facilitate absorption into the bloodstream. The process of manufacturing the fish oil determines the quality which also depends on the type of fish used and the purity standards followed when refining the oil. Emulsified forms of fish oil have led to improved digestion and absorption of EPA and DHA in human healthy volunteers.

Flavored emulsified liquid preparations provide a simplified approach to fish oil delivery; emulsion as new approach seems to have advantages in the digestion and absorption of fatty acids which will increase the bioavailability. Using a novel approach of fish oil emulsification, preliminary results have indicated that both the rate and the extent of absorption of the fatty acids, particularly EPA and DHA, may be increased when digested. The present study was designed to establish that fish oil pre-emulsified using a novel approach will lead to increased absorption of EPA and DHA compared with the non-emulsified form of the fish oil.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Neither the participant nor the research nurse will know the administration order of the different treatments administered. All plasma samples collected during the research project will be anonymized i.e. it will not be possible to identify the participant by his name since a number will be assigned to him. The code key linking the participant's name to his number will be stored, with access restricted to those designated by the principal investigator. The data file is also protected by a password.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female aged 18-60 years (inclusive Body mass index between 19 and 30 kg / m² (inclusive) at the pre-selection visit Individuals had to refrain from participating to other clinical studies involving experimental drugs for at least 30 days.
  • Female of childbearing potential must have an adequate contraception

排除标准

  • Person who consumed natural health products containing n-3 FAs in the last 6 months Allergy to fish or seafood Moderate-to-severe lipidemia (total cholesterol ≤ 240 mg/dl; LDL ≤ 160 mg/dl; Triglyceride ≤ 199 mg/dl) Tobacco or drug use Regular use of alcohol (females > 10 drinks, males > 14 drinks per week) Person who donated blood or had significant blood loss in the 56 days prior to study start Individuals with systolic blood pressure above 160 mmHg and diastolic blood pressure above 95 mmHg, or cardiac output at rest of less than 40 beats per minute or greater than 100 beats per minute.
  • People presenting any cardiovascular, pulmonary, haematological, neurological, psychiatric, endocrine or immunological problems as well as any gastrointestinal tract, liver, kidney disease or other conditions that could affect the absorption of lipids Hypothyroidism Positive human chorionic gonadotropin, a hormone secreted during pregnancy

结局指标

主要结局

The bioavailability of EPA and DHA in the plasma

时间窗: 0-24 hours

Define by the area under the curve between 0-24h

The absorption of EPA and DHA in the plasma

时间窗: 0-5 hours

Define by the area under the curve between 0-5h

次要结局

  • The maximum concentration of EPA and DHA in the plasma(0-24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mélanie Plourde

Associate professor, Department of medicine, Geriatric service

Université de Sherbrooke

研究点 (2)

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