Plasma diurnal variation in and absorption of EPA and DHA
Research type
Research Study
Full title
Diurnal variation of plasma concentration of EPA and DHA and absorption of doses taken at Hora Somni
IRAS ID
197927
Contact name
Philippa Jackson
Contact email
Sponsor organisation
Pronova BioPharma Norge AS
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
The bioavailability of the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) can be influenced by a number of factors including chemical structure of the fatty acid binding form and the food matrix with which the fatty acids are consumed. In addition to this, there is evidence from animals that the lipid metabolism follows a circadian pattern, although this has yet to be investigated in humans.
Pronovum is a dietary supplement that has been designed to improve bioavailability of omega-3 fatty acids compared with standard fish oil supplements by utilising a Self-MicroEmulsifying Drug Delivery System (SMEDDS). Pronovum is produced as a soft gelatine capsule containing fish oil based high concentrate omega-3 fatty acids. The in-situ formation of an emulsion occurs spontaneously when the capsule erupts in vivo and the SMEDDS solution comes in contact with the gastro-intestinal contents. The size of the microdroplets that are formed is in the lower micrometer range, the advantage of which is a much larger combined surface area compared to drops of oil which results in better access for pancreatic lipases. The resulting free fatty acids may then readily be absorbed during its passage through the upper small intestine resulting in an effective absorption of the oil.
Therefore duel objectives of this study are to determine the bioavailability in healthy middle aged adults of two formulations of fish oil taken at bed time using SMEDDS and to evaluate the diurnal variation in background plasma fatty acids.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
16/YH/0054
Date of REC Opinion
26 Feb 2016
REC opinion
Favourable Opinion