PKU GOLIKE PLUS 16+ – acceptability and tolerance market research study
Phenylketonuria
The study product (PKU GOLIKE PLUS 16+) is a phe-free protein substitute for the dietary management of patients with PKU, aged ≥16 years. Specifically, it is an amino acid mixture engineered with a modified-release technology (Physiomimic technology), containing 17 AAs, vitamins, minerals, other nutrients and two food additives forming a coating layer that modifies the organoleptic features of the product. The coating can indeed mask the typical taste and odour of the amino acids. This coating is also able to provide a gradual release (prolonged release over time) of the amino acids from the formulation, in order to mimic more closely the physiological absorption of amino acids from natural protein intake from food. In this study, the product prescription will be specified on an individual basis by the metabolic Dietitian responsible for the patients’ nutritional management and will be dependent on age and bodyweight of the patient. The new protein substitute can replace the amount of previous products patients were taking partially or totally (from 1 to 3 intakes/daily). Two visits are foreseen. At the baseline visit (Visit 1), all subjects will be asked to replace totally or partially their protein substitute/s with the study product (PKU GOLIKE PLUS 16+). The treatment with the study product will last for 7 days. As the study product contains vitamins and minerals, no supplementation is required. The last visit (Visit 2) will be performed at the end of the treatment period. During the 7-day period at home, patients will be asked to complete a daily diary by recording information on compliance (actual daily intake versus prescribed intake) and ease of use, and any gastrointestinal signs/symptoms. An Acceptability Questionnaire will also be completed at Visit 2; it will consider perceptions about visual appearance, smell, taste, after-taste, mouth feeling/palatability, overall liking of the product and patient’s potential interested at taking the new product on
1. Male and female patients with a diagnosis of phenylketonuria, aged ≥16 years 2. Subjects who are already taking a protein substitute for PKU and are willing to replace at least part of their prescription with the new study product for 7 days 3. Willing and able to give a written informed consent
1. Presence of serious concurrent illness 2. Presence of current illnesses that could interfere with the study (for instance, inflammatory status, etc) 3. Status of pregnancy or lactation, for females 4. Likelihood that the patient will not be compliant with the protocol requirements, in the judgement of the Lead Dietitian 5. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study 6. Use of antibiotics in the week prior to study entry 7. Use of sapropterin 8. Patients aged less than 16 years