Phenylketonuria (PKU)NCT02440932
Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis
A study testing Phenylketonuria-type diet in people with Phenylketonuria (PKU), run by University of Glasgow at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Phenylketonuria (PKU)
- What is being tested?
- Phenylketonuria-type diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult
- Body weight stable for previous 4 months
- Regular menstrual cycle (females)
Who cannot join
- Pregnancy or lactation (females)
- History of eating disorder
- History of gastrointestinal problems or surgery
- History of allergy
- History of chronic illness
- On any medication
Show all 10Show fewer
- Smoking
- On nutritional supplements
- Following specific diet
- Currently taking part in other research
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Nutrition, School of Medicine, University of Glasgow
Glasgow, G31 2ER
About this study
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.
- Conditions
- Phenylketonuria (PKU)
- Being tested
- Phenylketonuria-type diet, Normal (control) diet
- Keywords
- low Phenylalanine diet, PKU supplements, diet induced thermogenesis, appetite, body weight
- Medical subject headings
- Phenylketonurias, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylketonuria-type dietDietary supplement
Breakfast, lunch and open buffet dinner
Normal (control) dietOther
Breakfast, lunch and open buffet dinner
| Study group | Role | What they receive |
|---|---|---|
| Phenylketonuria-type diet | Experimental | Breakfast: one pouch of amino acid supplement (174 mls supplemented drink PKU cooler 20, Vitaflo®; 20 g protein, 9.4 g carbohydrates, 0.7 g Fat) Lunch: cheese sandwich [low protein bread (Juvela, UK), no protein vegan cheese (Viotros, UK)], low protein crackers (Vitaflo, UK), and low protein cookies (Juvela, UK).
Dinner: ad libitum buffet meal Receives: Dietary Supplement: Phenylketonuria-type diet; Other: Normal (control) diet |
| Normal diet | Other | Breakfast: 174 ml of milk (20 g protein, 9.4 g carbohydrates, 0.7 g Fat) Lunch: cheese sandwich, crackers, and cookies (regular foods) Dinner: ad libitum buffet meal Receives: Dietary Supplement: Phenylketonuria-type diet; Other: Normal (control) diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite hormone: peptide YY (PYY)
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)
Measured: 300 minutes
Appetite hormone: glucagon-like peptide-1 (GLP-1)
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)
Measured: 300 minutes
Appetite hormone: cholecystokinin (CCK)
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)
Measured: 300 minutes
Appetite hormone: insulin
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)
Measured: 300 minutes
Appetite hormone: ghrelin
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)
Measured: 300 minutes
Subjective appetite score
Visual analogue scale (VAS) collected at baseline and after each blood sample collection
Measured: 300 minutes
Diet induced thermogenesis
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
Measured: 300 minutes
Secondary outcomes (2)
Taste perception of PKU supplements/foods
Immediately after supplement ingestion and lunch consumption
Measured: 10 minutes
Consumption time for PKU supplements/foods
Maximum 5 minutes for supplement ingestion and maximum 20 minutes for lunch consumption
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phenylketonuria (PKU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Dalia Malkova, University of Glasgow
- Investigators
- Dalia Malkova, PhD, Study chair, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440932
- Sponsor's protocol ID
- 200130139
- Status last verified
- May 2016
- First submitted
- 30 Apr 2015
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Alfheeaid H, Gerasimidis K, Nastase AM, Elhauge M, Cochrane B, Malkova D. Impact of phenylketonuria type meal on appetite, thermic effect of feeding and postprandial fat oxidation. Clin Nutr. 2018 Jun;37(3):851-857. doi: 10.1016/j.clnu.2017.03.005. Epub 2017 Mar 8.
PubMed 28318688
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis
- ClinicalTrials.gov ID
- NCT02440932
- Acronym / sponsor ID
- 200130139
- Conditions
- Phenylketonuria (PKU)
- Keywords
- low Phenylalanine diet, PKU supplements, diet induced thermogenesis, appetite, body weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylketonuria-type diet | Experimental | Dietary Supplement: Phenylketonuria-type diet, Other: Normal (control) dietBreakfast: one pouch of amino acid supplement (174 mls supplemented drink PKU cooler 20, Vitaflo®; 20 g protein, 9.4 g carbohydrates, 0.7 g Fat) Lunch: cheese sandwich [low protein bread (Juvela, UK), no protein vegan cheese (Viotros, UK)], low protein crackers (Vitaflo, UK), and low protein cookies (Juvela, UK). Dinner: ad libitum buffet meal |
| Normal diet | Other | Dietary Supplement: Phenylketonuria-type diet, Other: Normal (control) dietBreakfast: 174 ml of milk (20 g protein, 9.4 g carbohydrates, 0.7 g Fat) Lunch: cheese sandwich, crackers, and cookies (regular foods) Dinner: ad libitum buffet meal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult
- Body weight stable for previous 4 months
- Regular menstrual cycle (females)
Key exclusion criteria (10 listed)
- Pregnancy or lactation (females)
- History of eating disorder
- History of gastrointestinal problems or surgery
- History of allergy
- History of chronic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenylketonuria-type dietBreakfast, lunch and open buffet dinner | Dietary supplement | Normal diet, Phenylketonuria-type diet |
| Normal (control) dietBreakfast, lunch and open buffet dinner | Other | Normal diet, Phenylketonuria-type diet |
Primary outcome
Appetite hormone: peptide YY (PYY)
Time frame: 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)
Time frame: 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: cholecystokinin (CCK)
Time frame: 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: insulin
Time frame: 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
Time frame: 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
Time frame: 300 minutes
Visual analogue scale (VAS) collected at baseline and after each blood sample collection
Diet induced thermogenesis
Time frame: 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
2 secondary outcomes
Taste perception of PKU supplements/foods
Time frame: 10 minutes
Consumption time for PKU supplements/foods
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Derived from this study: PubMed 28318688Alfheeaid H, Gerasimidis K, Nastase AM, Elhauge M, Cochrane B, Malkova D. Impact of phenylketonuria type meal on appetite, thermic effect of feeding and postprandial fat oxidation. Clin Nutr. 2018 Jun;37(3):851-857. doi: 10.1016/j.clnu.2017.03.005. Epub 2017 Mar 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalia Malkova, PhD study chair
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylketonuria-type diet in people with Phenylketonuria (PKU), run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite hormone: peptide YY (PYY) (time frame: 300 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.