Obesity
Conditions
Keywords
EPA, LC-PUFA, Orlistat, Obesity
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTFish oil enriched with EPA
DIETARY_SUPPLEMENTMAG-EPA oil
DRUGOrlistat
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be accretion of EPA in erythrocytes at 21days | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| • The secondary outcome will be the incorporation of EPA in plasma + chylomicrons | from baseline to day 21 |
Countries
Switzerland
Outcome results
None listed