Comparison of the Efficacy of Monoacylglycerol (MAG) and Triacylglycerol (TAG) to Deliver Long Chain Polyunsaturated Fatty Acids (LC-PUFA) Under Malabsorption Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The primary outcome will be accretion of EPA in erythrocytes at 21days
研究概览
简要总结
A potential application for unstructured monoacylglycerol (MAG) containing long chain polyunsaturated fatty acids (LC-PUFA)can be to provide essential fatty acids to humans who chronically consume lipases inhibitor such as Orlistat® for weigh lowering reasons. Indeed, it is predictable that chronic consumption of Orlistat® led to a depletion of essential fatty acids with time, therefore unstructured MAG containing LC-PUFA can be an option as a source of LC-PUFA for patients under Orlistat® treatment and hypothetically for subjects with other type of maldigestion/malabsorption. Potential applications of such concept are therefore related to disease conditions comprising low lipid digestion due to lipase activity insufficiency.
In the present study, in order to see the response information for eicosapentanoic acid (EPA) delivery, EPA will be provided either as a mixture of free monoacylglycerols or as triacylglycerol (TAG). The erythrocyte and plasma fatty acid composition from subjects under Orlistat® consumption will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-65
- •Sex female
- •Body Mass Index (BMI) ≥ 30kg/m2 and < 40kg/m2
- •Subjects willing to undergo treatment with Orlistat® (Xenical).
- •Having obtained her written informed consent before any study related procedure including the pre-inclusion period.
- •Subject exclusion criteria:
- •Binge eating disorder
- •Any other weight loss treatment(s) within the last 3 months
- •Vegetarians
- •History of metabolic, cardiovascular, hepatic or renal diseases
- •Obstructed bile duct
- •Diseases that could interfere with intestinal absorption History of abdominal / gastric surgery (except appendicectomy)
- •Use of drugs or illicit substances
- •Consumption of alcohol > 50 gr/week
- •Any other clinically significant abnormalities on screening laboratory evaluation (creatinine, Na, K, urique acide, ASAT, ALAT, Ph. Alc., yGT, Glycemia, total cholesterol, HDL, LDL, triglycerides) concentrations > 2.5 fold normal range
- •Pregnant or lactating mothers
- •Allergy to fish oil or other components (for e.g., gelatin or excepients of the capsule)
- •Use of any other supplements containing fish oil for the duration of the trial or 3 month before inclusion in trial.
- •Having donated blood or had a transfusion of blood/blood products during the trial and 3 months prior to screening or expected to do so during the study
- •Bleeding disorders
- •Subject who cannot be expected to comply with the study procedures.
- •Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study.
排除标准
- 未提供
研究组 & 干预措施
Fish oil enriched with EPA + ORLISTAT
The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.
The Orlistat capsules of 120mg (except for groups 1 and 2). 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.
干预措施: Fish oil enriched with EPA (Dietary Supplement)
Fish oil enriched with EPA + ORLISTAT
The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.
The Orlistat capsules of 120mg (except for groups 1 and 2). 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.
干预措施: Orlistat (Drug)
MAG-EPA
The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.
干预措施: MAG-EPA oil (Dietary Supplement)
MAG-EPA + ORLISTAT
The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.
The Orlistat capsules of 120mg (except for groups 1 and 2). 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.
干预措施: MAG-EPA oil (Dietary Supplement)
MAG-EPA + ORLISTAT
The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.
The Orlistat capsules of 120mg (except for groups 1 and 2). 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.
干预措施: Orlistat (Drug)
Fish oil enriched with EPA
The oil will be liquid form of 1g /capsule. 3 capsules will be administrated per day: one capsule to be swallowed with a glass of water before every major meal, 3 times a day for 21 days.
干预措施: Fish oil enriched with EPA (Dietary Supplement)
结局指标
主要结局
The primary outcome will be accretion of EPA in erythrocytes at 21days
时间窗: 21 days
次要结局
- • The secondary outcome will be the incorporation of EPA in plasma + chylomicrons(from baseline to day 21)