- Contribution of Diet Induced Thermogenesis (DIT) and Fat Oxidation to Body Fatness and Body Composition of Patients With Phenylketonuria - Contribution of Physical Activity Energy Expenditure and Energy Intake to Body Fatness and Body Composition of Patients With Phenylketonuria
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Basal metabolic rate (BMR)
研究概览
简要总结
This will be case-control study investigating whether dietary intake and components of energy expenditure such as Basal metabolic rate (BMR), physical activity energy expenditure (PAEE) and diet induce thermogenesis (DIT) are different between people with phenylketonuria (PKU) and matched healthy controls. Participants will be children and adults with PKU age between 10 to 45 years old, free from history of any acute and chronic illness. Participants will attend the Metabolic Research Unit at New Lister Building (NLB) after 12-hour overnight fasting refraining from alcohol consumption for at least 24 hours. Any planned exercise will be avoided during the 48 hours prior visit to the Metabolic Research Unit. Height, body weight and handgrip strength will be measured upon arrival at the unit. BMR will be assessed and participants will be asked to provide baseline saliva sample followed by consumption of 8 g deuterium water (D2O) diluted in drinking water. Normal or PKU-type isocaloric breakfast meal will then be provided based on intervention group-type. DIT will be measured 5 times for 3 hours, with each measurement lasting for 20 minutes. Two saliva samples will be collected at 3 and 3.5 hours after ingestion of D2O. Participants will be asked to perform an incremental intensity exercise test for 20 minutes on the treadmill during which expired air will be collected and accelerometer counts and heart rate will be measured. Participants will then be trained on how to recorded food intake and how to use accelerometers for habitual physical activity measurements. PKU participants (and their parents if ≤15 years old) will be asked to complete quality of life (QoL) questionnaires. Participants will be required to wear the accelerometer equipment for seven consecutive days excluding bedtime and keep a record of non-wear times. During these days, they will also prospectively record estimated food and beverages intake over four days including one weekend day.
详细描述
- Anthropometric measurements:
Height will be measured using a wall-mounted stadiometer to the nearest 0.01 meter. Body mass will be measured in kilograms using balance scale. Body mass index (BMI) will be calculated using the following formula: BMI = kg/m² [weight in kilograms/ height in meters²]. 2. Handgrip strength (kilograms):
Grip strength will be measured by using a handgrip dynamometer as a measure of strength and physical capacity. 3. Body composition determination, saliva samples collection, storage and analysis:
Body composition will be determined using the deuterium water (D2O) dilution technique. Participants will be provided a dose of 8 g of D2O diluted in drinking water. Participants will be asked to provide a baseline saliva samples and another samples will be obtained at 3 and 3.5 hrs after ingestion of the D2O. Samples will be stored in freezers at -20 °C. All samples will be analysed at Scottish Universities Environmental Research Centre (SUERC), Glasgow, for measurements of total body water (TBW) by means of Fourier Transform Infrared Spectrometry (FTIR). 4. Metabolic rate measurement:
Metabolic rate will be measured by means of computerised open-circuit ventilated hood system (Quark, Resting metabolic rate (RMR) ®, Italy). Rate of oxygen consumption (O2) and carbon dioxide production (CO2) will be recorded every 30 seconds for total duration of 20 minutes with 10 minute break. 5. Breakfast meal:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and adults with PKU between 10 to 45 years old
- •Free from history of any acute and chronic illness (other than PKU)
排除标准
- •Patients with learning or mobility disabilities
- •Patients who are deemed not competent to provide informed consent as judged by the clinical staff
- •Pregnant or lactating women
- •Participants who are not able to read, comprehend or communicate in English
结局指标
主要结局
Basal metabolic rate (BMR)
时间窗: 14 months
BMR by means of computerised open-circuit ventilated hood system (Quark RMR®, Italy).
Diet induce thermogenesis (DIT)
时间窗: 14 months
DIT will be measured by means of computerised open-circuit ventilated hood system (Quark RMR®, Italy).
Physical activity energy expenditure (PAEE)
时间窗: 14 months
PAEE will be calculated during rest, and continuous incremental exercise by establishing an individual calibration curves for counts accelerometer against rate of oxygen (O2) and rate of carbon dioxide (CO2).
Energy and macro-nutrient intake
时间窗: 14 months
Participants will be asked to estimate their food intake using household measures or natural unit sizes (e.g. slices of bread) and to record their intake for four days including one weekend day. Data from food diaries will be compared to reference UK photographic atlas of food portion sizes to estimate weight of food intake. Food and energy intake will then be calculated using the dietary software 2010 (The Robert Gordon University, Aberdeen, Scotland, UK).
次要结局
- Body composition(14 months)
- Quality of life assessment(14 months)
- Hand-grip strength(14 months)
研究者
Dr Konstantinos Gerasimidis
Lecturer in Clinical Nutrition
University of Glasgow