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

Phenylketonuria (PKU) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440932
• Other study ID #: 200130139
• Status: Completed
• Phase: N/A
• First received: April 30, 2015
• Last updated: May 20, 2016
• Start date: November 2014
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Phenylketonuria (PKU)
• Phenylketonurias

Intervention

Dietary Supplement:
• Phenylketonuria-type diet
Breakfast, lunch and open buffet dinner

Other:
• Normal (control) diet
Breakfast, lunch and open buffet dinner

Locations

Country	Name	City	State
United Kingdom	Human Nutrition, School of Medicine, University of Glasgow	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	300 minutes	No
Primary	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)	300 minutes	No
Primary	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)	300 minutes	No
Primary	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)	300 minutes	No
Primary	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)	300 minutes	No
Primary	Subjective appetite score	Visual analogue scale (VAS) collected at baseline and after each blood sample collection	300 minutes	No
Primary	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	300 minutes	No
Secondary	Taste perception of PKU supplements/foods	Immediately after supplement ingestion and lunch consumption	10 minutes	No
Secondary	Consumption time for PKU supplements/foods	Maximum 5 minutes for supplement ingestion and maximum 20 minutes for lunch consumption	20 minutes	No