Comparison of MAG and Fish Oil Efficacy

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of the Efficacy of Monoacylglycerol (MAG) and Triacylglycerol (TAG) to Deliver Long Chain Polyunsaturated Fatty Acids (LC-PUFA) Under Malabsorption Conditions

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Fish oil enriched with EPA
* Dietary Supplement: MAG-EPA oil
* Drug: Orlistat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Smokers 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish oil enriched with EPA + ORLISTAT<br>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. | Dietary Supplement: Fish oil enriched with EPA<br> <br> Drug: Orlistat<br> <br> |
| Active Comparator: MAG-EPA<br>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. | Dietary Supplement: MAG-EPA oil<br> <br> |
| Active Comparator: MAG-EPA + ORLISTAT<br>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. | Dietary Supplement: MAG-EPA oil<br> <br> Drug: Orlistat<br> <br> |
| Active Comparator: Fish oil enriched with EPA<br>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. | Dietary Supplement: Fish oil enriched with EPA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be accretion of EPA in erythrocytes at 21days |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • The secondary outcome will be the incorporation of EPA in plasma + chylomicrons |  | from baseline to day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LC-PUFA, EPA, Orlistat, Obesity