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临床试验/NCT04302285
NCT04302285已完成不适用

Impact of Single Exercise Session Conducted Prior to Phenylketonuria (PKU) Type Meal on Appetite Hormones, Metabolic Rate, Fat Oxidation and Energy Intake

University of Glasgow1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Peptide YY (PYY)

研究概览

简要总结

The study applied a randomized, crossover design with preliminary (screening) session and two sequenced experimental trials. Trials were marked as Control trial and Exercise trial. Participants were asked to either resting (Control trial) or exercising (Exercise trial) for one hour. In the two trials, appetite questionnaires were obtained, blood samples were collected, and metabolic rates were measured every 30 minutes. Participants in both trials were presented to a standard isocaloric PKU type meal at 120 min. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal at 300 min. Participants required to record their EI for the remainder of the experimental day using a self-recorded food diary. Two days prior the experimental trials participants refrained from exercise and alcohol intake. All data collection took place in the metabolic research unit at New Lister Building, Glasgow Royal Infirmary.

详细描述

Participants of the study were essentially healthy men with body mass index (BMI) ≤29 kg/m2 and aged between 22-35 years, recruited by advertisements and word of mouth. Study participants were required to be non-smokers, to have stable body weight for one month prior to study enrolment, and were not taking any medication, nutritional supplement or being on a special diet. Exclusion criteria included chronic illness, eating disorder and history of gastrointestinal operations which could interfere with the results of the study. Written informed consent were obtained prior commencing the study. The Ethics Committee of the collage of Medical Veterinary and Life Sciences, Glasgow University approved the study.

Preliminary session

Before joining the study, preliminary session was conducted for ~3 hours. Participants were informed to come to the metabolic research unit at New Lister Building, Glasgow Royal Infirmary to completed physical activity readiness questionnaire (PARQ), healthy screening questionnaire and International physical activity questionnaire. Only participants at light or moderate of physical activity level, answered "no" to all questions in PARQ and were in generally good health were eligible to complete the preliminary session. Subsequently, height and body mass were measured and a ~30 min submaximal exercise test was conducted at gradually increasing inclines. After 4 minutes of warming up period (3.5 km/hr and 0% incline), participants were walking at a constant speed of 6 km/hr with incline being increased by 2% every 4 min. The test was terminated when the heart rate (HR) reached 85% of maximal HR (HRmax) defined as 220 - age in years. During the test, participants were wearing a HR monitor and a face mask (to measure rate of oxygen consumption (V̇O2) and rate of carbon dioxide production (V̇CO2)). The HR monitor and the mask were both connected to the indirect calorimetry machine (Quark RMR®, COSMED, Italy). The obtained data was used to predict maximal oxygen consumption (V̇O2max) which was achieved by extrapolation of the HR against V̇O2 in order to calculate workload corresponds to 60% of V̇O2max.

Experimental trials

A randomisation scheme was generated using GraphPad Software 2018© to allocate participants to the experimental trials. Trials were marked as Control and Exercise by the researcher. Each participant started first trial according to allocated trial randomization. On the morning of each experiment trial, participants reported to the metabolic research unit between 08:00 and 09:00 after an overnight fast. Height, body mass and resting metabolic rate (RMR) were measured. A cannula was introduced into an antecubital vein and after an interval of 10 min, a baseline blood sample was obtained. Subsequently, an appetite questionnaire was completed. Participants were then asked to either resting (Control trial) or exercising (Exercise trial) for one hour. The Exercise trials were conducted under controlled laboratory conditions. Participants were exercising on the treadmill (Trackmaster Treadmills, Full Vision, Inc., Kansas, USA) at speed and grade corresponding to 60% of their V̇O2max. Participants were wearing a HR monitor and a face mask while exercising, connected to indirect calorimetry equipment (Quark RMR®, COSMED, Italy). V̇O2 and V̇CO2 in the inspired and expired air were measured to calculate fat and CHO oxidation and rate of physical activity energy expenditure (PAEE) by using indirect calorimetry equations described by Frayn and Macdonald (1997).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
22 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy men with
  • Body mass index (BMI) ≤29 kg/m2
  • Aged 22-35 years
  • Stable body weight for one month prior to study enrolment, and were
  • Not taking any medication, nutritional supplement or being on a special diet.

排除标准

  • Chronic illness
  • Eating disorder
  • History of gastrointestinal operations which could interfere with the results of the study

结局指标

主要结局

Peptide YY (PYY)

时间窗: 300 minutes through study completion, an average of 12 days

Changes in plasma concentration of fasting and postprandial PYY were measured during the Exercise and Control trials.

Glucagon-like peptide-1 (GLP-1)

时间窗: 300 minutes through study completion, an average of 12 days

Changes in plasma concentration of fasting and postprandial GLP-1 were measured during the Exercise and Control trials.

次要结局

  • Subjective appetite score(300 minutes through study completion, an average of 12 days)
  • Fat oxidation(300 minutes through study completion, an average of 12 days)
  • Growth differentiation factor 15 (GDF-15)(300 minutes through study completion, an average of 12 days)
  • Dietary intake(24 hours through study completion, an average of 12 days)
  • Diet induced thermogenesis(300 minutes through study completion, an average of 12 days)

研究者

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

Dr Dalia Malkova

Dr

University of Glasgow

研究点 (1)

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