Table 2.
Baseline Demographics | |||||||
Subject | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
Age (years) | 11 | 11 | 12 | 9 | 7 | 11 | 15 |
Weight (kg) | 60.3 | 53.3 | 45.9 | 25.8 | 26.6 | 45.6 | 55.8 |
Height (cm) | 152.3 | 147.5 | 155.8 | 124.5 | 119.7 | 154.8 | 174.4 |
PKU classification | Classical | Classical | Moderate | Classical | Classical | Classical | Classical |
Blood Phe on diagnosis (µmol/L) | 1700 | 1680 | 900 | 1390 | 1590 | 2520 | 2690 |
Gender | Female | Female | Male | Male | Male | Male | Male |
Ethnicity | Pakistani | Pakistani | White European | White British | Mixed race | White British | White British |
Diet and Protein-Substitute Profile | |||||||
Natural protein allowance (g/day) | 4.0 | 4.0 | 7.0 | 3.0 | 6.5 | 7.5 | 18.0 |
Protein equivalent from usual protein substitutes g/day (g/kg/day) | 60.0 (1.0) | 60.0 (1.1) | 60.0 (1.3) | 80.0 (3.1) | 60.0 (2.3) | 80.0 (1.7) | 60.0 (1.2) |
Number of different protein substitutes/day | 2 | 2 | 2 | 1 | 2 | 2 | 1 |
Number of doses/day | 3 | 3 | 4 | 4 | 4 | 4 | 3 |
Study Product Treatment Schedule and Preparation | |||||||
Daily dose (g) | 24.0 | 24.0 | 24.0 | 32.0 | 24.0 | 24.0 | 24.0 |
Protein equivalent from study product (g) | 15.0 | 15.0 | 15.0 | 20.0 | 15.0 | 15.0 | 15.0 |
Total daily protein equivalent from all protein substitutes (g) 1 | 55.0 | 55.0 | 55.0 | 80.0 | 60.0 | 75.0 | 55.0 |
Protein equivalent from study product
(% of daily intake) |
27.3 | 27.3 | 27.3 | 25.0 | 25.0 | 20.0 | 27.3 |
Method of administration | In fruit juice | In fruit juice | Food and drinks | In fruit juice | In fruit juice and food | Fruit smoothie | Smoothie |
Timing of administration of study product | Evening | Evening | Evening | Evening | Morning midday and bedtime | Morning or evening | Morning or evening |
Comments on
study product |
Left some bits behind on cup | Last bit was hard to take | No comments | No comments | No comments | Required blender to mix | No comments |
1 Subject 1, Subject 2 and Subject 6 were 5 g of protein short of their pre-study dose due to differences in sizes of protein substitute sachets/pouches when incorporating the study product with existing protein-substitute diet plan. Abbreviations: Phe: phenylalanine; PKU: phenylketonuria.