ACCEPTABILITY STUDY OF A NEW PROTEIN SUBSTITUTE (more than 8years)
Research type
Research Study
Full title
ACCEPTABILITY OF A NEW PROTEIN SUBSTITUTE ENRICHED IN VITAMINS, MINERALS, LONG-CHAIN POLYUNSATURATED FATTY ACIDS AND COW’S MILK LIPIDS FOR CHILDREN OLDER THAN 8 YEARS & ADULTS WITH PKU
IRAS ID
217752
Contact name
Sarah Adam
Contact email
Sponsor organisation
Lactalis Research and Development
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
This is a study regarding the acceptability of a new amino-acid protein substitute for patients with phenylketonuria from 8 years old through to adults. The objective of the study is to investigate if the new formula Nophenyl 8+ enriched in LCPUFAs (n-6 and n-3 long-chain polyunsaturated fatty acids) and cow’s milk lipids is acceptable and well tolerated in patients with phenylketonuria older than 8 years old (8 years old included). This is a milk-based product in powder form which has to be reconstituted. The tolerance and acceptability will be measured by a self-reported questionnaire. This is an observational study where 10 subjects will be recruited (to obtain at least 5 completed questionnaires) for a 7-day trial of the new protein substitute formula Nophenyl 8+ in order to evaluate its tolerability and acceptability.
REC name
West of Scotland REC 1
REC reference
17/WS/0141
Date of REC Opinion
31 Aug 2017
REC opinion
Further Information Favourable Opinion