Body Composition, Energy Intake and Expenditure in People With Phenylketonuria
NCT ID: NCT03309345
Last Updated: 2017-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
26 participants
OBSERVATIONAL
2017-01-20
2019-01-20
Brief Summary
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Detailed Description
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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:
Participants in phenylketonuria (PKU) group will receive a breakfast based on PKU-type foods. Participants in control group will receive a similar breakfast based on normal foods with calories content and weight being matched between the groups.
6. Measurements of physical activity (PA) and physical activity energy expenditure (PAEE):
ActiGraph accelerometer (GT3X+®) will be used to measure and record acceleration of participant's physical activity. The participants will have to wear them for seven consecutive days. They should record the time they put the monitor on in the morning and when taking it off in the evening in their activity diaries. They also have to keep notes of time and reason if they take the monitor off during the day.
Individual calibration curves for counts against rate of O2 and rate of CO2 will be established during rest, and continuous incremental exercise test on the treadmill. Each participant will conduct walking/ running test with starting speed of 2 km/h being increased by 1 km/h every 4 minutes. The test will be stopped when heart rate (HR) just reaches 80 % of maximal heart rate (HRmax) defined as 220 - age. During this incremental test, participants will wear both ActiGraph accelerometer and face mask connected to indirect calorimetry equipment (Quark RMR®, Italy) to measure rate of O2 and rate of CO2.
7. Dietary analyses:
Participants will record their food intake by food portion size estimation method. Participants will be asked 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 computerised program.
8. Quality of life assessment:
PKU participants' quality of life will be assessed by means of validated PKU-specific Health-related Quality of Life Questionnaires (PKU-QOL). The questionnaires cover the physical, emotional, and social impacts of PKU and its treatment on patients' lives and come along with a software to calculate PKU-QoL scores.
9. Clinical data on history of disease activity:
Information about disease management relevant to the study (i.e. records of phenylalanine levels, weight and height status, and number of protein exchanges and dietary compliance, quantity and types of prescribed PKU foods and amino acid supplements) will be collected from the patients' medical notes. The data will be obtained for one year prior to the participants' intended day of study start.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Case group, PKU group
Children and adults (10 - 45 years old) with PKU attending the metabolic medicine clinics in the area of National Health Services (NHS) Greater Glasgow and Clyde (GGC) will be approached for recruitment. Participants will be free from history of acute and chronic illness (other than PKU) requiring regular appointments to the doctor and/or chronic use of medication or major gastrointestinal surgery where major part of the gut has been resected as these conditions are known to impact on energy expenditure and dietary intake. Pregnant or lactating women will also be excluded from participation. People with learning or mobility difficulties or those with incapacity to provide informed consent will be excluded too. The clinical treatment team will evaluate patients' capacity to consent before considering them to participate in the study.
No intervention
No intervention as this is an observational study investigates the difference between PKU ant matched healthy control in terms of energy components and dietary intake
Control group, healthy control
Gender, BMI and age matched healthy people will be recruited as a control group. Pregnant or lactating women will be excluded from participation. Those with any chronic illnesses or bone injuries will also be excluded.
No intervention
No intervention as this is an observational study investigates the difference between PKU ant matched healthy control in terms of energy components and dietary intake
Interventions
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No intervention
No intervention as this is an observational study investigates the difference between PKU ant matched healthy control in terms of energy components and dietary intake
Eligibility Criteria
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Inclusion Criteria
* Free from history of any acute and chronic illness (other than PKU)
Exclusion Criteria
* 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
10 Years
45 Years
ALL
Yes
Sponsors
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University of Glasgow
OTHER
Responsible Party
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Dr Konstantinos Gerasimidis
Lecturer in Clinical Nutrition
Principal Investigators
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Dalia Malkova, BSc,MSc,PhD
Role: STUDY_DIRECTOR
University of Glasgow
Konstantinos Gerasimidis, PhD,MSc,APHNutr
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Barbara Cochrane, BSc,MSc
Role: STUDY_DIRECTOR
Queen Elizabeth University Hospital
Sarah Adam, BSc,PGC
Role: STUDY_DIRECTOR
Glasgow Royal Infirmary Hospital
Peter Galloway, Med,MB CHB,DCH,FRCP,FRCPath
Role: STUDY_DIRECTOR
Glasgow Royal Infirmary Hospital
Locations
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University of Glasgow
Glasgow, Scotland, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Nouf Alghamdi, BSc,MSc
Role: primary
Hani Alfheeaid, BSc,MSc
Role: backup
Other Identifiers
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R&D:GN16ME448P, REC:16/SW/0288
Identifier Type: -
Identifier Source: org_study_id