Comparison of MAG and Fish Oil Efficacy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01797757
First received: February 19, 2013
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Obesity
Dietary Supplement: Fish oil enriched with EPA
Dietary Supplement: MAG-EPA oil
Drug: Orlistat

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Comparison of the Efficacy of Monoacylglycerol (MAG) and Triacylglycerol (TAG) to Deliver Long Chain Polyunsaturated Fatty Acids (LC-PUFA) Under Malabsorption Conditions

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • The primary outcome will be accretion of EPA in erythrocytes at 21days [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • The secondary outcome will be the incorporation of EPA in plasma + chylomicrons [ Time Frame: from baseline to day 21 ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Dietary Supplement: Fish oil enriched with EPA Drug: Orlistat
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.

Dietary Supplement: MAG-EPA oil Drug: Orlistat
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797757

Locations
Switzerland
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Vittorio Giusti, MD CHUV Centre Hospitalier Universitaire Vaudois
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01797757     History of Changes
Other Study ID Numbers: 10.29.NRC
Study First Received: February 19, 2013
Last Updated: February 21, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Nestlé:
EPA
LC-PUFA
Orlistat
Obesity

Additional relevant MeSH terms:
Nutrition Disorders
Obesity
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014