Bioavailability of Omega-3 Food Supplement in Healthy Subjects

Pronovum - An Open-label, Randomized, Single-dose Study to Evaluate the Bioavailability of Omega-3 Food Supplements in Healthy Male and Female Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02376608

Enrollment

Registered

2015-03-03

Start date

2014-08-31

Completion date

2014-09-30

Last updated

2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biological Availability

Brief summary

The study will evaluate the relative bioavailability of Pronovum PRF-037 and Pronovum PRF-041 with PronovaPure 150:150 EE EU and Eskimo-3 (500 mg omega-3 acid triglyceride containing 80 mg EPA and 50 mg DHA per gram oil) in healthy subjects.

Interventions

DIETARY_SUPPLEMENTPronova Pure 150:500 EE EU

Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period

DIETARY_SUPPLEMENTPronovum PRF-037

DIETARY_SUPPLEMENTPronovum PRF-041

DIETARY_SUPPLEMENTEskimo-3

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Healthy volunteers

Yes

Inclusion criteria

* males or females * any ethnic origin * BMI 18.5 - 30.0 kg/m2 * generally in good health * signed informed consent

Exclusion criteria

* males or females not willing to use appropriate contraception * prescribed systemic or topical medication within 14 days and slow release medication considered to be active within 14 days. * omega-3 fatty acids or fish oil within 2 weeks of dosing. * any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days * any medication incl. St.John's Worth known to chronically alter drug absorption/elimination within 30 days * Subjects still present in clinical study or in the past 3 months * recent blood donation * drug allergy or significant allergic disease * allergic or hypersensitivity to omega-3 acids, fish, soya, oleic acid, sesame oil or other constituents in pharma preparation * high consumption of alcohol * high consumption of tobacco * hepatitis or HIV * vegetarians * earlier participated in or withdrawn from the study * not willing to follow dietary restrictions * frequent occurence of migraine attacks * subjects that should not participate according to investigator

Design outcomes

Primary

Measure	Time frame
Area under curve of omega-3 food supplements under light fed conditions in healthy subjects.	Pharmacikinetics up to 36 hours post-dose
Peak plasma concentration of omega-3 food supplements under light fed conditions in healthy subjects.	Pharmacikinetics up to 36 hours post-dose

Secondary

Measure	Time frame
Number of participants with adverse events as a measure of safety and tolerability.	During entire study period, an expected average of 7 weeks from screening to last visit.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026