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Plasma Level of Various Omega-3 Lipids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118999
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: OM3-FFA Dietary Supplement: OM3-MAG Dietary Supplement: OM3-EE Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Plasma Level of Various Omega-3 Lipids
Actual Study Start Date : February 28, 2017
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : August 31, 2017

Arm Intervention/treatment
Experimental: OM3-FFA
Omega3 linked to free fatty acids
Dietary Supplement: OM3-MAG
Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design

Dietary Supplement: OM3-EE
Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design

Experimental: OM3 -MAG
Omega3 linked to Monoacylglycerol
Dietary Supplement: OM3-FFA
Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design

Dietary Supplement: OM3-EE
Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design

Experimental: OM3-EE
Omega3 linked to ethylester
Dietary Supplement: OM3-FFA
Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design

Dietary Supplement: OM3-MAG
Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design




Primary Outcome Measures :
  1. AUC(0-24h) Plasma OM3 [ Time Frame: From Time 0 hour to Time 24 hours ]
    Baseline-adjusted total plasma OM3 AUC(0-24h)


Secondary Outcome Measures :
  1. Pharmacokinetic parameters (AUC) for EPA and DHA [ Time Frame: From Time 0 hour to Time 24 hours ]
    AUC(0-24h) Plasma EPA and DHA

  2. Pharmacokinetic parameters (Cmax) for EPA and DHA [ Time Frame: From Time 0 hour to Time 24 hours ]
    Cmax Plasma EPA and DHA

  3. Pharmacokinetic parameters (Tmax) for EPA and DHA [ Time Frame: From Time 0 hour to Time 24 hours ]
    Tmax Plasma EPA and DHA



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    i. 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:

    1. Dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates (to the opinion of the investigator)
    2. 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
  • 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

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): NCT03118999


Locations
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Switzerland
Nestlé Research Center / Clinical Development Unit / Metabolic Unit
Lausanne 26, Vaud, Switzerland, 1000
Sponsors and Collaborators
Nestlé
Investigators
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Study Director: Bernard Cuénoud Nestec Ltd.
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03118999    
Other Study ID Numbers: 16.18.BIO
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No