Bioavailability of Omega-3 Food Supplement in Healthy Subjects

Pronova

Status and phase: Completed; Phase 1

Conditions: Biological Availability

Treatments: Dietary Supplement: Pronovum PRF-041; Dietary Supplement: Eskimo-3; Dietary Supplement: Pronova Pure 150:500 EE EU; Dietary Supplement: Pronovum PRF-037

Study type: Interventional

Funder types: Industry

Identifiers

NCT02376608

CTN00714101

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex

Volunteers: Accepts Healthy Volunteers

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• earlier participated in or withdrawn from the study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

Trial design

24 participants in 4 patient groups

Pronova Pure 150:500 EE EU

Active Comparator group

Description:

2 × PronovaPure 150:500 EE EU

Treatment:

Dietary Supplement: Pronova Pure 150:500 EE EU

Dietary Supplement: Eskimo-3

Dietary Supplement: Pronovum PRF-037

Dietary Supplement: Pronovum PRF-041

Pronovum PRF-037

Active Comparator group

Description:

2 × Pronovum PRF-037

Treatment:

Dietary Supplement: Pronova Pure 150:500 EE EU

Dietary Supplement: Eskimo-3

Dietary Supplement: Pronovum PRF-037

Dietary Supplement: Pronovum PRF-041

Pronovum PRF-041

Active Comparator group

Description:

2 × Pronovum PRF-041

Treatment:

Dietary Supplement: Pronova Pure 150:500 EE EU

Dietary Supplement: Eskimo-3

Dietary Supplement: Pronovum PRF-037

Dietary Supplement: Pronovum PRF-041

Eskimo-3

Active Comparator group

Description:

3 × Eskimo-3

Treatment:

Dietary Supplement: Pronova Pure 150:500 EE EU

Dietary Supplement: Eskimo-3

Dietary Supplement: Pronovum PRF-037

Dietary Supplement: Pronovum PRF-041