Clinical trial NCT02440932: Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis
Official title: Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phenylketonuria (PKU)
Keywords: low Phenylalanine diet
PKU supplements
diet induced thermogenesis
appetite
body weight
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Appetite hormone: peptide YY (PYY)
timeFrame: 300 minutes
measure: Appetite hormone: glucagon-like peptide-1 (GLP-1)
timeFrame: 300 minutes
measure: Appetite hormone: cholecystokinin (CCK)
timeFrame: 300 minutes
measure: Appetite hormone: insulin
timeFrame: 300 minutes
measure: Appetite hormone: ghrelin
timeFrame: 300 minutes
measure: Subjective appetite score
timeFrame: 300 minutes
measure: Diet induced thermogenesis
timeFrame: 300 minutes
Secondary outcomes:
measure: Taste perception of PKU supplements/foods
timeFrame: 10 minutes
measure: Consumption time for PKU supplements/foods
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Human Nutrition, School of Medicine, University of Glasgow
Study officials:
affiliation: University of Glasgow
name: Dalia Malkova, PhD
role: STUDY_CHAIR
References:
citation: 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.