Completed

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

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What is being tested

Fish oil enriched with EPA

+ Orlistat

+ MAG-EPA oil

Dietary SupplementDrug
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Screening Study

Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorSociété des Produits Nestlé (SPN)
Last updated: February 22, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01797757
Principal SponsorSociété des Produits Nestlé (SPN)
Last updated: February 22, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Screening Study

Screening studies test new methods to find diseases or risk factors early—before any symptoms appear. This helps catch health issues sooner, when they may be easier to treat.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweightObesity

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Group II

Active Comparator
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.

Group III

Active Comparator
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.

Group IV

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

CHUV Centre Hospitalier Universitaire Vaudois

Lausanne, SwitzerlandOpen CHUV Centre Hospitalier Universitaire Vaudois in Google Maps
CompletedOne Study Center