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Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis

Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02440932
Enrollment
26
Registered
2015-05-12
Start date
2014-11-30
Completion date
2016-03-31
Last updated
2016-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phenylketonuria (PKU)

Keywords

low Phenylalanine diet, PKU supplements, diet induced thermogenesis, appetite, body weight

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTPhenylketonuria-type diet

Breakfast, lunch and open buffet dinner

OTHERNormal (control) diet

Breakfast, lunch and open buffet dinner

Sponsors

University of Glasgow
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1. Healthy adult 2. Body weight stable for previous 4 months 3. Regular menstrual cycle (females)

Exclusion criteria

1. Pregnancy or lactation (females) 2. History of eating disorder 3. History of gastrointestinal problems or surgery 4. History of allergy 5. History of chronic illness 6. On any medication 7. Smoking 8. On nutritional supplements 9. Following specific diet 10. Currently taking part in other research

Design outcomes

Primary

MeasureTime frameDescription
Diet induced thermogenesis300 minutesMetabolic 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
Appetite hormone: ghrelin300 minutesPlasma 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 score300 minutesVisual analogue scale (VAS) collected at baseline and after each blood sample collection
Appetite hormone: peptide YY (PYY)300 minutesPlasma 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)300 minutesPlasma 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)300 minutesPlasma 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: insulin300 minutesPlasma 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)

Secondary

MeasureTime frameDescription
Consumption time for PKU supplements/foods20 minutesMaximum 5 minutes for supplement ingestion and maximum 20 minutes for lunch consumption
Taste perception of PKU supplements/foods10 minutesImmediately after supplement ingestion and lunch consumption

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026