Comparison of MAG and Fish Oil Efficacy

Nestlé

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: MAG-EPA oil; Drug: Orlistat; Dietary Supplement: Fish oil enriched with EPA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01797757

10.29.NRC

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 4 patient groups

Fish oil enriched with EPA + ORLISTAT

Active Comparator group

Description:

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.

Treatment:

Drug: Orlistat

Dietary Supplement: Fish oil enriched with EPA

MAG-EPA

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: MAG-EPA oil

MAG-EPA + ORLISTAT

Active Comparator group

Description:

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.

Treatment:

Drug: Orlistat

Dietary Supplement: MAG-EPA oil

Fish oil enriched with EPA

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Fish oil enriched with EPA