PKU Low Calorie Drink Study
Research type
Research Study
Full title
Evaluating the compliance, acceptability, safety and tolerance of a lower calorie protein substitute for the dietary management of phenylketonuria in children and adults – a pilot study
IRAS ID
244645
Contact name
Rebecca Stratton
Contact email
Duration of Study in the UK
2 years, 4 months, 31 days
Research summary
The dietary management of phenylketonuria (PKU) requires the consumption of a prescribable phenylalanine (Phe)-free protein substitute and calculated intake of Phe containing foods to keep blood Phe concentrations within the desired range.
Anecdotal evidence of weight management being challenging in patients with PKU has been reported, most likely due to the restrictive diet affecting food choices and patients’ subsequent relationship with food. Weight concern is common in patients with PKU and many healthcare professionals and patient groups provide support to help patients with their weight management. The choice of protein substitute can be a factor affecting weight management, and some patients perceive the calorie content of existing protein substitutes to be contributing to their weight challenges.
As such, Nutricia Advanced Medical Nutrition has developed a new prescribable lower calorie phenylalanine-free protein substitute for the dietary management of PKU in adults and children aged 3 years and over (PKU Lophlex Lite LQ). It is specifically designed to meet the needs of those patients who require a lower calorie protein substitute option to aid their overall dietary management of PKU. PKU Lophlex Lite LQ is composed of an adapted mixture of other essential and non-essential amino acids (excluding Phe), carbohydrates, fats, vitamins and minerals, and is enriched with DHA. The amino acids in PKU Lophlex Lite LQ provide 20g protein equivalent (PE) per 125 ml pouch.
This intervention study aims to evaluate the compliance, acceptability, safety and tolerance of PKU Lophlex Lite LQ, while also capturing information related to blood amino acid levels, nutrient intake and anthropometry. 30 eligible adults and children (≥ 3 years) will be recruited. Following a 3 day baseline period in which patients will continue with their usual protein substitute, patients will receive the study product for a period of 28 days in addition to appropriate nutritional management.
REC name
London - Central Research Ethics Committee
REC reference
18/LO/0650
Date of REC Opinion
21 Jun 2018
REC opinion
Further Information Favourable Opinion