Comparison study of O3FA supplement formulations.
Research type
Research Study
Full title
A randomised cross-over trial to compare the bioavailability, acceptability and tolerability of omega-3 fatty acids in a drink carton formulation with an equivalent dose of omega-3 fatty acids in soft gelatin capsule form.
IRAS ID
166337
Contact name
M A Hull
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
Oily fish such as mackerel and sardines contain natural omega-3 fatty acids (O3FAs) such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). O3FAs are commonly used as nutritional supplements, with scientific evidence suggesting numerous health benefits including improved cognitive performance, maintenance of a healthy heart and even possible anti-cancer effects. These supplements are traditionally taken as capsules, although recently developed fruit-flavoured drink cartons are now available e.g. Smartfish® Nutrifriend Cachexia (NFCax). There is however a lack of scientific data available related to the O3FA juice supplements and therefore we wish to compare taking two Smartfish® NFCax drinks per day with the equivalent dose (4 g total EPA/DHA) as four traditional O3FA capsules per day.
The primary comparison between the capsules and cartons is the level of O3FAs within the blood after 8 weeks. Other areas under investigation include the acceptability and tolerability of both types of O3FA supplement, the effects on cognitive performance (memory and reaction time)and the effect of O3FA supplementation on the bacteria found within the gut.
We plan to recruit 20 healthy volunteers aged 50 years or over. The study is a randomised cross-over design and therefore participants will be asked to take both the O3FA-containing capsules and Smartfish NFCax drinks separately during two 8 week intervention periods. There will be a 12 week 'washout' period at the end of each intervention period during which no supplements are taken.
The duration of the study is 10 months. Participants will be asked to attend the Human Appetite Research Unit (HARU) at the University of Leeds on five separate occasions at which they will provide blood and urine samples. At these visits participants will also be asked to complete computerised cognitive tests. Prior to each visit participants will be asked to submit a stool sample for analysis.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
15/YH/0142
Date of REC Opinion
29 Apr 2015
REC opinion
Further Information Favourable Opinion