Status:
COMPLETED
Comparison of MAG and Fish Oil Efficacy
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Obesity
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 lip...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01797757
Start Date
January 1 2012
End Date
December 1 2012
Last Update
February 22 2013
Active Locations (1)
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1
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011