Comparison of MAG and Fish Oil Efficacy

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797757
• Other study ID #: 10.29.NRC
• Status: Completed
• Phase: N/A
• First received: February 19, 2013
• Last updated: February 21, 2013
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Fish oil enriched with EPA

• MAG-EPA oil

Drug:
• Orlistat

Locations

Country	Name	City	State
Switzerland	CHUV Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be accretion of EPA in erythrocytes at 21days		21 days	No
Secondary	• The secondary outcome will be the incorporation of EPA in plasma + chylomicrons		from baseline to day 21	No