Plasma Level of Various Omega-3 Lipids

Healthy Clinical Trial

Official title:

Plasma Level of Various Omega-3 Lipids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118999
• Other study ID #: 16.18.BIO
• Status: Completed
• Phase: N/A
• Start date: February 28, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: September 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Switzerland	Nestlé Research Center / Clinical Development Unit / Metabolic Unit	Lausanne 26	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-24h) Plasma OM3	Baseline-adjusted total plasma OM3 AUC(0-24h)	From Time 0 hour to Time 24 hours
Secondary	Pharmacokinetic parameters (AUC) for EPA and DHA	AUC(0-24h) Plasma EPA and DHA	From Time 0 hour to Time 24 hours
Secondary	Pharmacokinetic parameters (Cmax) for EPA and DHA	Cmax Plasma EPA and DHA	From Time 0 hour to Time 24 hours
Secondary	Pharmacokinetic parameters (Tmax) for EPA and DHA	Tmax Plasma EPA and DHA	From Time 0 hour to Time 24 hours