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Body Composition, Energy Intake and Expenditure in People With Phenylketonuria

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ClinicalTrials.gov Identifier: NCT03309345
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Konstantinos Gerasimidis, University of Glasgow

Brief Summary:
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.

Condition or disease Intervention/treatment
Phenylketonuria (PKU) Other: No intervention

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 26 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: - 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
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : January 20, 2019
Estimated Study Completion Date : January 20, 2019


Group/Cohort Intervention/treatment
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.
Other: 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.
Other: 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




Primary Outcome Measures :
  1. Basal metabolic rate (BMR) [ Time Frame: 14 months ]
    BMR by means of computerised open-circuit ventilated hood system (Quark RMR®, Italy).

  2. Diet induce thermogenesis (DIT) [ Time Frame: 14 months ]
    DIT will be measured by means of computerised open-circuit ventilated hood system (Quark RMR®, Italy).

  3. Physical activity energy expenditure (PAEE) [ Time Frame: 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).

  4. Energy and macro-nutrient intake [ Time Frame: 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).



Secondary Outcome Measures :
  1. Body composition [ Time Frame: 14 months ]
    Will be determined using the deuterium water (D2O) dilution technique

  2. Quality of life assessment [ Time Frame: 14 months ]
    PKU participants' quality of life will be assessed by means of validated PKU-specific Health related Quality of Life Questionnaires (PKU-QOL)

  3. Hand-grip strength [ Time Frame: 14 months ]
    Grip strength will be measured by using a hand-grip dynamometer as a measure of strength and physical capacity



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Ages Eligible for Study:   10 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Eligible patients will be identified from the clinical appointment lists held by the medical team of the metabolic medicine clinics in NHS GGC. A member of the treatment team (Mrs Barbara Cochrane or other members of the primary management clinical teams) will send an introductory letter about the study and the study information leaflet to those participants who are eligible to participate. This will give adequate time for the participants and their carers to consider the study prior to their subsequent clinical appointment. To increase recruitment rate, the researchers will present the study at the PKU group sessions, cooking and social events that are organised by the local clinical team

Controls will be recruited by means of poster advertisement and by university's email-broadcasting and word of mouth in the campus of the University of Glasgow, and other public areas (libraries, train/bus stations).

Criteria

Inclusion Criteria:

  • Children and adults with PKU between 10 to 45 years old
  • Free from history of any acute and chronic illness (other than PKU)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309345


Contacts
Contact: Nouf A Alghamdi, BSc,MSc +447437450063 n.alghamdi.1@research.gla.ac.uk
Contact: Hani Alfheeaid, BSc,MSc +447533260555 h.alfheeaid.1@research.gla.ac.uk

Locations
United Kingdom
University of Glasgow Recruiting
Glasgow, Scotland, United Kingdom, G31 2ER
Contact: Nouf Alghamdi, BSc,MSc    +447437450063    n.alghamdi.1@research.gla.ac.uk   
Contact: Hani Alfheeaid, BSc,MSc    +447533260555    h.alfheeaid.1@research.gla.ac.uk   
Principal Investigator: Konstantinos Gerasimidis, PhD,MSc,APHNutr         
Sub-Investigator: Dalia Malkova, BSc,MSc,PhD         
Sponsors and Collaborators
University of Glasgow
Investigators
Study Director: Dalia Malkova, BSc,MSc,PhD University of Glasgow
Principal Investigator: Konstantinos Gerasimidis, PhD,MSc,APHNutr University of Glasgow
Study Director: Barbara Cochrane, BSc,MSc Queen Elizabeth University Hospital
Study Director: Sarah Adam, BSc,PGC Glasgow Royal Infirmary Hospital
Study Director: Peter Galloway, Med,MB CHB,DCH,FRCP,FRCPath Glasgow Royal Infirmary Hospital

Responsible Party: Dr Konstantinos Gerasimidis, Lecturer in Clinical Nutrition, University of Glasgow
ClinicalTrials.gov Identifier: NCT03309345     History of Changes
Other Study ID Numbers: R&D:GN16ME448P, REC:16/SW/0288
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Phenylketonurias
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases