Bioavailability of Omega-3 Food Supplements in Healthy Subjects

Pronova

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: Pronovum PRF-037; Dietary Supplement: PronovaPure 150:500 triglycerides; Dietary Supplement: Pronovum PRF-048; Dietary Supplement: PronovaPure 500:200 TG; Dietary Supplement: Pronovum PRF-047

Study type: Interventional

Funder types: Industry

Identifiers

NCT02376621

CTN00714102

Details and patient eligibility

About

The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted conditions in healthy adult subjects. Each subject will participate in 5 treatment periods. The order of treatments will be in accordance with the randomisation schedule.There will be a minimum of 4 treatment-free days between each treatment period. On each dosing occasion, subjects will be fasted for at least 10 hours overnight, prior to the morning of dosing. Twenty-four subjects will be enrolled to complete dosing of 20 subjects.

Enrollment: 24 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• males or females
• any ethnic origin
• age 40 - 65 years
• 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 taken within 14 days
• taken supplements containing omega-3 faty acids or fish oil last 14 days or any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days
• taken any medication including St. John's Worth known to alter drug absorption within 30 days
• subjects participating in a clinical study past 3 months
• recent blood donation
• significant history of drug allergy or any allergic disease
• allergy or hypersensitivity to omega-3 fatty acids, fish, soya, oleic acid, sesame oil or other constituents of pharmaceutical preparation.
• high consumption of tobacco
• high consumption of alcohol
• other significant medical history or physical findings (including HIV,hepatitis)
• vegetarians
• not willing to follow dietary restrictions
• frequent migraine attacks
• previously taken part in or withdrawn from study or according to investigator should not participate.

Trial design

24 participants in 5 patient groups

PronovaPure 150:500 triglycerides

Active Comparator group

Description:

3 × PronovaPure 150:500 triglycerides (TG) European Union (EU)

Treatment:

Dietary Supplement: PronovaPure 150:500 triglycerides

Dietary Supplement: Pronovum PRF-048

Dietary Supplement: PronovaPure 500:200 TG

Dietary Supplement: Pronovum PRF-047

Dietary Supplement: Pronovum PRF-037

Pronovum PRF-048

Active Comparator group

Description:

3 × Pronovum PRF-048

Treatment:

Dietary Supplement: PronovaPure 150:500 triglycerides

Dietary Supplement: Pronovum PRF-048

Dietary Supplement: PronovaPure 500:200 TG

Dietary Supplement: Pronovum PRF-047

Dietary Supplement: Pronovum PRF-037

Pronovum PRF-037

Active Comparator group

Description:

3 × Pronovum PRF-037

Treatment:

Dietary Supplement: PronovaPure 150:500 triglycerides

Dietary Supplement: Pronovum PRF-048

Dietary Supplement: PronovaPure 500:200 TG

Dietary Supplement: Pronovum PRF-047

Dietary Supplement: Pronovum PRF-037

PronovaPure 500:200 TG

Active Comparator group

Description:

3 × PronovaPure 500:200 TG EU

Treatment:

Dietary Supplement: PronovaPure 150:500 triglycerides

Dietary Supplement: Pronovum PRF-048

Dietary Supplement: PronovaPure 500:200 TG

Dietary Supplement: Pronovum PRF-047

Dietary Supplement: Pronovum PRF-037

Pronovum PRF-047

Active Comparator group

Description:

3 × Pronovum PRF-047

Treatment:

Dietary Supplement: PronovaPure 150:500 triglycerides

Dietary Supplement: Pronovum PRF-048

Dietary Supplement: PronovaPure 500:200 TG

Dietary Supplement: Pronovum PRF-047

Dietary Supplement: Pronovum PRF-037