Comparison of MAG and Fish Oil Efficacy

February 21, 2013 updated by: Société des Produits Nestlé (SPN)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • CHUV centre hospitalier universitaire vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fish oil enriched with EPA + ORLISTAT

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.
Drug: Orlistat
Dietary supplement: Fish oil enriched with EPA
Active Comparator: MAG-EPA
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.
Dietary supplement: MAG-EPA oil
Active Comparator: MAG-EPA + ORLISTAT

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.
Drug: Orlistat
Dietary supplement: MAG-EPA oil
Active Comparator: Fish oil enriched with EPA
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.
Dietary supplement: Fish oil enriched with EPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome will be accretion of EPA in erythrocytes at 21days
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
• The secondary outcome will be the incorporation of EPA in plasma + chylomicrons
Time Frame: from baseline to day 21
from baseline to day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Vittorio Giusti, MD, CHUV centre hospitalier universitaire vaudois

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 22, 2013

Study Record Updates

Last Update Posted (Estimate)

February 22, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.29.NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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