Plasma Level of Various Omega-3 Lipids

Nestlé

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: OM3-FFA; Dietary Supplement: OM3-EE; Dietary Supplement: OM3-MAG

Study type: Interventional

Funder types: Industry

Identifiers

NCT03118999

16.18.BIO

Details and patient eligibility

About

The primary objective of this study is to evaluate the pharmacokinetic properties of 3 OM3 oils after a single-dose administration in healthy volunteers

Full 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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

OM3-FFA

Experimental group

Description:

Omega3 linked to free fatty acids

Treatment:

Dietary Supplement: OM3-MAG

Dietary Supplement: OM3-EE

OM3 -MAG

Experimental group

Description:

Omega3 linked to Monoacylglycerol

Treatment:

Dietary Supplement: OM3-FFA

Dietary Supplement: OM3-EE

OM3-EE

Experimental group

Description:

Omega3 linked to ethylester

Treatment:

Dietary Supplement: OM3-FFA

Dietary Supplement: OM3-MAG