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临床试验/NCT02440932
NCT02440932已完成不适用

Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis

University of Glasgow2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Appetite hormone: peptide YY (PYY)

研究概览

简要总结

Low-phenylalanine diets are commonly prescribed to people with phenylketonuria (PKU), an inborn disease which causes accumulation of amino acid phenylalanine (Phe) in the blood. High blood Phe levels can cause mental, behavioural, neurological, and physical problems. Thus, low-phenylalanine diets help patients to manage their condition but it is not clear whether they have an impact on appetite, energy intake and changes in body weight. This is important to explore as prevalence of obesity in this population is rising high. This study aims to find out the effect of PKU-type meals on appetite, appetite biomarkers, and post-meal energy expenditure. The investigators will recruit 26 healthy adults and ask them to participate in two experimental trials. On one occasion the participants will be asked to consume a PKU-supplemented drink followed by a PKU type-lunch and on another occasion the supplement and lunch will be based on normally consumed foods. Series of blood samples will be taken and appetite will be assessed during both experiments. Both experimental trials will finish with consuming an "all-you-can-eat" buffet.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adult
  • Body weight stable for previous 4 months
  • Regular menstrual cycle (females)

排除标准

  • Pregnancy or lactation (females)
  • History of eating disorder
  • History of gastrointestinal problems or surgery
  • History of allergy
  • History of chronic illness
  • On any medication
  • On nutritional supplements
  • Following specific diet
  • Currently taking part in other research

结局指标

主要结局

Appetite hormone: peptide YY (PYY)

时间窗: 300 minutes

Plasma concentration at baseline (0 minute) and after ingestion of supplement (at 30, 60 and 90 minutes) and lunch (at 120, 150,180, 210, 240, 270 and 300 minutes)

Appetite hormone: glucagon-like peptide-1 (GLP-1)

时间窗: 300 minutes

Plasma concentration at baseline (0 minute) and after ingestion of supplement (at 30, 60 and 90 minutes) and lunch (at 120, 150,180, 210, 240, 270 and 300 minutes)

Appetite hormone: ghrelin

时间窗: 300 minutes

Plasma concentration at baseline (0 minute) and after ingestion of supplement (at 30, 60 and 90 minutes) and lunch (at 120, 150,180, 210, 240, 270 and 300 minutes)

Subjective appetite score

时间窗: 300 minutes

Visual analogue scale (VAS) collected at baseline and after each blood sample collection

Appetite hormone: insulin

时间窗: 300 minutes

Plasma concentration at baseline (0 minute) and after ingestion of supplement (at 30, 60 and 90 minutes) and lunch (at 120, 150,180, 210, 240, 270 and 300 minutes)

Diet induced thermogenesis

时间窗: 300 minutes

Metabolic rate by means of computerised open-circuit ventilated hood system collected at baseline and after each blood sample collection for the duration of 20 minutes

Appetite hormone: cholecystokinin (CCK)

时间窗: 300 minutes

Plasma concentration at baseline (0 minute) and after ingestion of supplement (at 30, 60 and 90 minutes) and lunch (at 120, 150,180, 210, 240, 270 and 300 minutes)

次要结局

  • Taste perception of PKU supplements/foods(10 minutes)
  • Consumption time for PKU supplements/foods(20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Dalia Malkova

Senior Lecturer

University of Glasgow

研究点 (2)

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