NCT01797757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

8 months

First QC Date

February 19, 2013

Last Update Submit

February 21, 2013

Conditions

Obesity

Keywords

EPALC-PUFAOrlistatObesity

Outcome Measures

Primary Outcomes (1)

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

    21 days

Secondary Outcomes (1)

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

    from baseline to day 21

Study Arms (4)

Fish oil enriched with EPA + ORLISTAT

ACTIVE COMPARATOR

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 EPADrug: Orlistat

MAG-EPA

ACTIVE COMPARATOR

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

MAG-EPA + ORLISTAT

ACTIVE COMPARATOR

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 oilDrug: Orlistat

Fish oil enriched with EPA

ACTIVE COMPARATOR

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

Interventions

Fish oil enriched with EPADIETARY_SUPPLEMENT
Fish oil enriched with EPAFish oil enriched with EPA + ORLISTAT
MAG-EPA oilDIETARY_SUPPLEMENT
MAG-EPAMAG-EPA + ORLISTAT
OrlistatDRUG
Fish oil enriched with EPA + ORLISTATMAG-EPA + ORLISTAT

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Sex female
  • Body Mass Index (BMI) ≥ 30kg/m2 and \< 40kg/m2
  • Subjects willing to undergo treatment with Orlistat® (Xenical).

You may not qualify if:

  • 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)
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 27707818DERIVED

MeSH Terms

Conditions

Obesity

Interventions

1-eicosapentaenoylglycerolOrlistat

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Study Officials

  • Vittorio Giusti, MD

    CHUV Centre Hospitalier Universitaire Vaudois

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2013

First Posted

February 22, 2013

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

CH(1)