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Trial record 37 of 69 for:    ORLISTAT

Comparison of MAG and Fish Oil Efficacy

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ClinicalTrials.gov Identifier: NCT01797757
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : February 22, 2013
Sponsor:
Information provided by (Responsible Party):
Nestlé

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.


Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Fish oil enriched with EPA Dietary Supplement: MAG-EPA oil Drug: Orlistat Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

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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.

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



Primary Outcome Measures :
  1. The primary outcome will be accretion of EPA in erythrocytes at 21days [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. • The secondary outcome will be the incorporation of EPA in plasma + chylomicrons [ Time Frame: from baseline to day 21 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797757


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01797757     History of Changes
Other Study ID Numbers: 10.29.NRC
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013
Keywords provided by Nestlé:
EPA
LC-PUFA
Orlistat
Obesity
Additional relevant MeSH terms:
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Orlistat
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents