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

Sponsor
University of Glasgow (Other)
Overall Status
Completed
CT.gov ID
NCT02440932
Collaborator
(none)
26
1
2
16
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Phenylketonuria-type diet
  • Other: Normal (control) diet
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Official Title:
Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced Thermogenesis
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phenylketonuria-type diet

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

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

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

Other: Normal diet

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Appetite hormone: peptide YY (PYY) [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)

  2. Appetite hormone: glucagon-like peptide-1 (GLP-1) [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)

  3. Appetite hormone: cholecystokinin (CCK) [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)

  4. Appetite hormone: insulin [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)

  5. Appetite hormone: ghrelin [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)

  6. Subjective appetite score [300 minutes]

    Visual analogue scale (VAS) collected at baseline and after each blood sample collection

  7. Diet induced thermogenesis [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

Secondary Outcome Measures

  1. Taste perception of PKU supplements/foods [10 minutes]

    Immediately after supplement ingestion and lunch consumption

  2. Consumption time for PKU supplements/foods [20 minutes]

    Maximum 5 minutes for supplement ingestion and maximum 20 minutes for lunch consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Human Nutrition, School of Medicine, University of Glasgow Glasgow United Kingdom G31 2ER

Sponsors and Collaborators

  • University of Glasgow

Investigators

  • Study Chair: Dalia Malkova, PhD, University of Glasgow

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Dalia Malkova, Senior Lecturer, University of Glasgow
ClinicalTrials.gov Identifier:
NCT02440932
Other Study ID Numbers:
  • 200130139
First Posted:
May 12, 2015
Last Update Posted:
May 23, 2016
Last Verified:
May 1, 2016
Keywords provided by Dr Dalia Malkova, Senior Lecturer, University of Glasgow
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2016