Bioavailability of 5 different Omega-3 Food Supplements
Research type
Research Study
Full title
Nutrition Products - An Open-Label, Randomised, Single Dose Study to Evaluate the Bioavailability of Omega-3 Based Dietary Supplements under Fasting Conditions in Healthy Male and Female Subjects
IRAS ID
165019
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Pronova BioPharma Norge AS
Eudract number
2014-001883-36
Duration of Study in the UK
0 years, 1 months, 28 days
Research summary
Pronovum capsules ( study food supplement ) contain PronovaPure omega-3 concentrates which are derived from crude fish oil. Pronovum capsules are available in different formulations which differ in terms of choice of additives. These are designed to have an improved absorption compared to other omega-3 fish oil products.
This study will evaluate PronovaPure 150:500 TG EU, Pronovum PRF 048 , Pronovum PRF 037, PronovaPure 500:200 TG EU and Pronovum PRF 047 in healthy male and female volunteers.
This is an open label study which means both the volunteers and study staff will know what study drug given at each occasion.
In total up to 48 volunteers will be enrolled depending on the data from a recent study involving Pronovum products. Each volunteer will receive single oral dose of study drug in the fasted state.
Each volunteer will participate in 5 treatment periods, residing at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 1 (approximately 16 hours post dose) of Treatment Period 1 only. Subjects will return to the CRU at 24 hours and 36 hours post dose for blood draw. During Treatment Periods 2, 3, 4, and 5, subjects will return to the CRU on the morning of Day 1 (at least 1 hour prior to dosing) and will be discharged from the CRU at approximately 16 hours post dose. Subjects will return to the CRU at 24 hours and 36 hours post dose for blood draw. There will be a minimum of 4 treatment free days between each treatment period.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/1314
Date of REC Opinion
24 Oct 2014
REC opinion
Further Information Favourable Opinion