HealthyNCT03118999
Plasma Level of Various Omega-3 Lipids
A study testing OM3-FFA, OM3-MAG and OM3-EE in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The primary objective of this study is to evaluate the pharmacokinetic properties of 3 OM3 oils after a single-dose administration in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OM3-FFA, OM3-MAG and OM3-EE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Feb 2017to 31 Aug 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years old
- BMI in the normal and overweight range (18.5 to 29.9 kg/m2)
- Able to understand and to sign written informed consent prior to trial entry
- Informed consent signed
Who cannot join
- Food allergy
- Documented clinically relevant disease impacting the endpoints of the study or the safety of the subject, as determined by the medical (screening) visit:
- Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc. ii. Known hypertriglyceridemia (on anamnesis) iii. Known Type2 Diabetes Mellitus
- Under medication that may impact:
- Dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates (to the opinion of the investigator)
- Coagulation (blood thinning medications, anticoagulants). Indeed, OM3 have been shown to possibly exert some bleeding by themselves that may increase the bleeding effects of aspirin and anticoagulants
Show all 12Show fewer
- Having taken omega-3, EPA/DHA, fish oil supplementation for more than two consecutive weeks during the last 2 months
- Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
- Subjects not willing and/or not able to comply with scheduled visits and with the requirements of the study protocol, including trial products consumption and food restriction
- Pregnancy (on anamnesis)
- Any direct collaborator of the study leader (Dr. Maurice Beaumont)
- Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Nestlé Research Center / Clinical Development Unit / Metabolic Unit
Lausanne, Canton of Vaud, 1000
About this study
The primary objective of this study is to evaluate the pharmacokinetic properties of 3 OM3 oils after a single-dose administration in healthy volunteers
Read the detailed description
This is a single center, open design, randomized, controlled, cross-over trial with 3 test periods and 3 products (one test period per product). The three different test periods will be separated by a washout period of at least 6 days (up to 21 days).
- Conditions
- Healthy
- Being tested
- OM3-FFA, OM3-MAG, OM3-EE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OM3-FFADietary supplement
Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design
OM3-MAGDietary supplement
Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design
OM3-EEDietary supplement
Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design
| Study group | Role | What they receive |
|---|---|---|
| OM3-FFA | Experimental | Omega3 linked to free fatty acids Receives: Dietary Supplement: OM3-MAG; Dietary Supplement: OM3-EE |
| OM3 -MAG | Experimental | Omega3 linked to Monoacylglycerol Receives: Dietary Supplement: OM3-FFA; Dietary Supplement: OM3-EE |
| OM3-EE | Experimental | Omega3 linked to ethylester Receives: Dietary Supplement: OM3-FFA; Dietary Supplement: OM3-MAG |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-24h) Plasma OM3
Baseline-adjusted total plasma OM3 AUC(0-24h)
Measured: From Time 0 hour to Time 24 hours
Secondary outcomes (3)
Pharmacokinetic parameters (AUC) for EPA and DHA
AUC(0-24h) Plasma EPA and DHA
Measured: From Time 0 hour to Time 24 hours
Pharmacokinetic parameters (Cmax) for EPA and DHA
Cmax Plasma EPA and DHA
Measured: From Time 0 hour to Time 24 hours
Pharmacokinetic parameters (Tmax) for EPA and DHA
Tmax Plasma EPA and DHA
Measured: From Time 0 hour to Time 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start28 Feb 2017
- Primary completion30 Apr 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single center, open design, randomized, controlled, cross-over trial with 3 test periods and 3 food supplements containing omega3 (one test period per product).
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard Cuénoud, Study director, Nestec Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118999
- Sponsor's protocol ID
- 16.18.BIO
- Status last verified
- Sep 2018
- First submitted
- 30 Mar 2017
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Level of Various Omega-3 Lipids
- ClinicalTrials.gov ID
- NCT03118999
- Acronym / sponsor ID
- 16.18.BIO
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
The primary objective of this study is to evaluate the pharmacokinetic properties of 3 OM3 oils after a single-dose administration in healthy volunteers
Detailed description
This is a single center, open design, randomized, controlled, cross-over trial with 3 test periods and 3 products (one test period per product). The three different test periods will be separated by a washout period of at least 6 days (up to 21 days).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single center, open design, randomized, controlled, cross-over trial with 3 test periods and 3 food supplements containing omega3 (one test period per product).
| Arm | Type | Receives |
|---|---|---|
| OM3-FFA | Experimental | Dietary Supplement: OM3-MAG, Dietary Supplement: OM3-EEOmega3 linked to free fatty acids |
| OM3 -MAG | Experimental | Dietary Supplement: OM3-FFA, Dietary Supplement: OM3-EEOmega3 linked to Monoacylglycerol |
| OM3-EE | Experimental | Dietary Supplement: OM3-FFA, Dietary Supplement: OM3-MAGOmega3 linked to ethylester |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 65 years old
- BMI in the normal and overweight range (18.5 to 29.9 kg/m2)
- Able to understand and to sign written informed consent prior to trial entry
- Informed consent signed
Key exclusion criteria (12 listed)
- Food allergy
- Documented clinically relevant disease impacting the endpoints of the study or the safety of the subject, as determined by the medical (screening) visit:
- Under medication that may impact:
- Having taken omega-3, EPA/DHA, fish oil supplementation for more than two consecutive weeks during the last 2 months
- Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
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 |
|---|---|---|
| OM3-FFAComparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design | Dietary supplement | OM3 -MAG, OM3-EE |
| OM3-MAGComparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design | Dietary supplement | OM3-EE, OM3-FFA |
| OM3-EEComparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design | Dietary supplement | OM3 -MAG, OM3-FFA |
Primary outcome
AUC(0-24h) Plasma OM3
Time frame: From Time 0 hour to Time 24 hours
Baseline-adjusted total plasma OM3 AUC(0-24h)
3 secondary outcomes
Pharmacokinetic parameters (AUC) for EPA and DHA
Time frame: From Time 0 hour to Time 24 hours
Pharmacokinetic parameters (Cmax) for EPA and DHA
Time frame: From Time 0 hour to Time 24 hours
Pharmacokinetic parameters (Tmax) for EPA and DHA
Time frame: From Time 0 hour to Time 24 hours
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 20 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Bernard Cuénoud study director
Nestec Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OM3-FFA, OM3-MAG and OM3-EE in people with Healthy, 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 4 inclusion and 12 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 20 Sep 2018. 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?
AUC(0-24h) Plasma OM3 (time frame: From Time 0 hour to Time 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2018.