ObesityNCT01797757
Comparison of MAG and Fish Oil Efficacy
A study testing Fish oil enriched with EPA, MAG-EPA oil and Orlistat in people with Obesity, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fish oil enriched with EPA, MAG-EPA oil and Orlistat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 23Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Comparison of the Efficacy of Monoacylglycerol (MAG) and Triacylglycerol (TAG) to Deliver Long Chain Polyunsaturated Fatty Acids (LC-PUFA) Under Malabsorption Conditions
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.
- Conditions
- Obesity
- Being tested
- Fish oil enriched with EPA, MAG-EPA oil, Orlistat
- Keywords
- EPA, LC-PUFA, Orlistat, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil enriched with EPADietary supplement
MAG-EPA oilDietary supplement
OrlistatDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Fish oil enriched with EPA; Drug: 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. Receives: 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. Receives: Dietary Supplement: MAG-EPA oil; Drug: 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. Receives: Dietary Supplement: Fish oil enriched with EPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be accretion of EPA in erythrocytes at 21days
Measured: 21 days
Secondary outcomes (1)
• The secondary outcome will be the incorporation of EPA in plasma + chylomicrons
Measured: from baseline to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vittorio Giusti, MD, Principal investigator, CHUV Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797757
- Sponsor's protocol ID
- 10.29.NRC
- Status last verified
- Feb 2013
- First submitted
- 19 Feb 2013
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27707818
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Monoacylglycerol (MAG) and Triacylglycerol (TAG) to Deliver Long Chain Polyunsaturated Fatty Acids (LC-PUFA) Under Malabsorption Conditions
- ClinicalTrials.gov ID
- NCT01797757
- Acronym / sponsor ID
- 10.29.NRC
- Conditions
- Obesity
- Keywords
- EPA, LC-PUFA, Orlistat, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fish oil enriched with EPA + ORLISTAT | Active comparator | Dietary Supplement: Fish oil enriched with EPA, Drug: OrlistatThe 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. |
| MAG-EPA | Active comparator | Dietary Supplement: MAG-EPA oilThe 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. |
| MAG-EPA + ORLISTAT | Active comparator | Dietary Supplement: MAG-EPA oil, Drug: OrlistatThe 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. |
| Fish oil enriched with EPA | Active comparator | Dietary Supplement: Fish oil enriched with EPAThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fish oil enriched with EPA | Dietary supplement | Fish oil enriched with EPA, Fish oil enriched with EPA + ORLISTAT |
| MAG-EPA oil | Dietary supplement | MAG-EPA, MAG-EPA + ORLISTAT |
| Orlistat | Drug | Fish oil enriched with EPA + ORLISTAT, MAG-EPA + ORLISTAT |
Primary outcome
The primary outcome will be accretion of EPA in erythrocytes at 21days
Time frame: 21 days
1 secondary outcome
• The secondary outcome will be the incorporation of EPA in plasma + chylomicrons
Time frame: from baseline to day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
- Derived from this study: PubMed 27707818Cruz-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vittorio Giusti, MD principal investigator
CHUV Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish oil enriched with EPA, MAG-EPA oil and Orlistat in people with Obesity, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be accretion of EPA in erythrocytes at 21days (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01797757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013.