SNAP: Study Nutrients in Adult PKU
关键词
抽象
描述
The aim of this explorative cross-sectional study is to gain quantitative insights on blood nutrient levels of adult PKU patients on a protein substitute.
日期
最后验证: | 08/31/2019 |
首次提交: | 02/26/2019 |
提交的预估入学人数: | 02/26/2019 |
首次发布: | 02/27/2019 |
上次提交的更新: | 09/22/2019 |
最近更新发布: | 09/23/2019 |
实际学习开始日期: | 04/14/2019 |
预计主要完成日期: | 08/31/2020 |
预计完成日期: | 12/30/2020 |
状况或疾病
相
手臂组
臂 | 干预/治疗 |
---|---|
PKU subjects | |
Age and sex-matched non-PKU comparison subjects |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | - Inclusion Criteria: Both PKU and Non-PKU comparison subjects: 1. Age ≥18 years 2. Willing and able to provide signed informed consent PKU specific inclusion criteria 3. PKU patients identified by newborn screening and started low Phe diet before 1 month age 4. Usage of at least one Phe-free protein substitute (i.e. an amino acid mixture including micronutrients) on a daily basis for at least 26 consecutive weeks up to Visit 1 Non-PKU comparison subjects specific inclusion criteria: 5. Same age- (±3 years) and sex as an included PKU subject - Exclusion Criteria: Both PKU and Non-PKU comparison subjects: 1. For women: Currently pregnant or lactating 2. Current psychiatric disorders 3. Current Substance Use Disorders (as described in DSM V) 4. Current use of psychotropic and/or inotropic medication 5. Omega-3, antioxidant, (multi)vitamin and/or (multi)mineral supplement use within six weeks prior to entry in the study 6. Severe hepatic, thyroid or renal dysfunction 7. No acute illnesses like flu, diarrhea, or vomiting (subjects should be symptom free for a week prior to V1) 8. Participation in any other clinical intervention studies involving test products concomitantly or within six weeks prior to entry into the study 9. Other family members taking part in this study PKU subject specific exclusion criteria: 10. Use of BH4, or drugs that may interfere with main outcomes Non-PKU comparison subjects specific exclusion criteria: 11. Any condition or special diet (e.g. vegan or vegetarian diet) that effects the metabolism and/or normal dietary pattern/intake 12. A first or second degree relative with inborn errors of metabolism 13. Living together with someone with inborn errors of metabolism (e.g. partner, spouse or roommate) |
结果
主要结果指标
1. Blood nutritional status [day 1]
次要成果指标
1. Blood nutritional status [day 1]
2. Nutrient intake [day 1 - day 7]
3. Subjective cognitive well-being [day 1 - day 7]