NL-OMON50188已完成不适用
An exploratory matched case-control study to measure blood nutrient levels of adult PKU patients on a protein substitute. - SNAP: Study Nutrients in Adult PK
utricia Research0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Age >=18 years
- •2. Written informed consent
- •3. Same age- (±3 years) and sex as an included PKU subject
排除标准
- •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 (exclusion due to
- •inotropic medication use only if main goal or prescription is to alter the
- •contractability of the heart) six weeks prior to V1.
- •5. Omega-3, antioxidant, (multi)vitamin (other than vitamin D) and/or
- •(multi)mineral supplement use within six weeks prior to entry in the study (for
- •NCRU: prior to V1). Vitamin D supplementation is allowed
- •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. (for
- •NCRU: prior to V1).
- •9. Other family members taking part in this study
- •10. Any condition (e.g. celiac disease, anorexia, bulimia, gastrointestinal
- •tract disorders) or special diet (e.g. vegan or vegetarian diet, professional
- •athletes, people actively aiming to lose weight) that effects the metabolism
- •and/or normal dietary pattern/intake
- •11. A first or second degree relative with inborn errors of metabolism
- •12. Living together with someone with inborn errors of metabolism (e.g.
- •partner, spouse or roommate).
- •13. NCRU specific: Employees of Nutricia Research and/or partners, parents,
- •children and brothers/sisters of employees
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