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Comparison of MAG and Fish Oil Efficacy

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Fish oil enriched with EPA
MAG-EPA oil
Orlistat
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Obesity focused on measuring EPA, LC-PUFA, Orlistat, Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • CHUV Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Fish oil enriched with EPA + ORLISTAT

MAG-EPA

MAG-EPA + ORLISTAT

Fish oil enriched with EPA

Arm Description

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.

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 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.

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.

Outcomes

Primary Outcome Measures

The primary outcome will be accretion of EPA in erythrocytes at 21days

Secondary Outcome Measures

• The secondary outcome will be the incorporation of EPA in plasma + chylomicrons

Full Information

First Posted
February 19, 2013
Last Updated
February 21, 2013
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01797757
Brief Title
Comparison of MAG and Fish Oil Efficacy
Official Title
Comparison of the Efficacy of Monoacylglycerol (MAG) and Triacylglycerol (TAG) to Deliver Long Chain Polyunsaturated Fatty Acids (LC-PUFA) Under Malabsorption Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
EPA, LC-PUFA, Orlistat, Obesity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish oil enriched with EPA + ORLISTAT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MAG-EPA
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MAG-EPA + ORLISTAT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fish oil enriched with EPA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil enriched with EPA
Intervention Type
Dietary Supplement
Intervention Name(s)
MAG-EPA oil
Intervention Type
Drug
Intervention Name(s)
Orlistat
Primary Outcome Measure Information:
Title
The primary outcome will be accretion of EPA in erythrocytes at 21days
Time Frame
21 days
Secondary Outcome Measure Information:
Title
• The secondary outcome will be the incorporation of EPA in plasma + chylomicrons
Time Frame
from baseline to day 21

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vittorio Giusti, MD
Organizational Affiliation
CHUV Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUV Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27707818
Citation
Cruz-Hernandez C, Destaillats F, Thakkar SK, Goulet L, Wynn E, Grathwohl D, Roessle C, de Giorgi S, Tappy L, Giuffrida F, Giusti V. Monoacylglycerol-enriched oil increases EPA/DHA delivery to circulatory system in humans with induced lipid malabsorption conditions. J Lipid Res. 2016 Dec;57(12):2208-2216. doi: 10.1194/jlr.P070144. Epub 2016 Oct 5.
Results Reference
derived

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Comparison of MAG and Fish Oil Efficacy

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