A Pilot Study for the PKU Carriers Trial: Evaluating the Impact of PKU Carrier Status on Cognition, Mental Health, Blood Pressure and L-phenylalanine Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Stop Signal Reaction Time (Response Inhibition)
研究概览
简要总结
This is a clinical intervention pilot/feasibility study of PKU carriers (cases) and non-carriers (controls). Upon completing the informed consent process, participants will complete baseline measures of chronic mental health prior to the intervention (PHQ-9, GAD-7, BIS-Brief). Participants will attend the Human Nutraceutical Research Unit (HNRU) at the University of Guelph, fasted, and first undergo baseline measures of cognition and acute mental health (mood) and provide samples or saliva, urine and dried blood spots to evaluate phenylalanine (Phe), tyrosine (Tyr) and their metabolites (PAH pathway functioning). Participants will also complete a brief questionnaire which will include age, sex, ethnicity, income, weight and height (measured using a stadiometer and calibrated weigh scale), and confirmation that participants arrived to the lab fasted (i.e. have only had water to drink and no other foods/beverages prior to analyses). Blood pressure will also be measured at baseline. Following baseline tests, participants will consume a pure L-Phe supplement dosed at 100 mg/kg mixed into 250 mL water with 1 tsp white sugar. Blood pressure will be repeated at 1-hour post-L-Phe consumption. Two-hours postprandial, participants will repeat the cognitive tests and acute mental health (mood) assessment, blood pressure measurement and provide follow-up saliva, urine and dried blood spot samples. Participants will also be asked to report any side effects they experienced with the L-Phe consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Known carrier or non-carrier of PKU
- •At least 18 years of age
- •Comfortable fasting the morning of the study (no food or drink other than water)
排除标准
- •Diagnosed with: PKU, severe neurodegenerative conditions affecting cognition (e.g. Alzheimer's, Parkinson's, dementia), melanoma, hypertension, liver disease and/or kidney disease
- •Taking a Monoamine Oxidase Inhibitor anti-depressant
- •Pregnant or breastfeeding
结局指标
主要结局
Stop Signal Reaction Time (Response Inhibition)
时间窗: Change from baseline to 2-hours post L-Phe supplementation
次要结局
- Stop Signal Delay(Change from baseline to 2-hours post L-Phe supplementation)
- Mood(Change from baseline to 2-hours post L-Phe supplementation)
- Individual Coefficient of Variance (Variability in Reaction Times)(Change from baseline to 2-hours post L-Phe supplementation)
- Phenylalanine Levels(Change from baseline to 2-hours post L-Phe supplementation)
- Blood Pressure(Change from baseline to 1-hour and 2-hours post L-Phe supplementation)
- Working Memory(Change from baseline to 2-hours post L-Phe supplementation)
- Tyrosine Levels(Change from baseline to 2-hours post L-Phe supplementation)
- Tyrosine Metabolites: e.g. L-DOPA, dopamine, norepinephrine, epinephrine, p-hydroxyphenylpyruvate, homogentisic acid, fumarate, others(Change from baseline to 2-hours post L-Phe supplementation)
- Phenylalanine Metabolites: e.g.phenylethylamine, tyramine, phenylpyruvate, others(Change from baseline to 2-hours post L-Phe supplementation)
研究者
Justine Keathley
Assistant Professor
University of Guelph