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OpenTrials
Completed

NCT Number: NCT01797757

Comparison of MAG and Fish Oil Efficacy

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHUV Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fish oil enriched with EPA

Dietary Supplement

MAG-EPA oil

Dietary Supplement

Orlistat

Drug

Primary outcomes

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

    Time frame: 21 days

Secondary outcomes

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

    Time frame: from baseline to day 21

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 22, 2013
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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