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

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ClinicalTrials.gov Identifier: NCT02440932
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Dalia Malkova, University of Glasgow

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
Phenylketonuria (PKU) Dietary Supplement: Phenylketonuria-type diet Other: Normal (control) diet Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : November 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016


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

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




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. Subjective appetite score [ Time Frame: 300 minutes ]
    Visual analogue scale (VAS) collected at baseline and after each blood sample collection

  7. 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


Secondary Outcome Measures :
  1. Taste perception of PKU supplements/foods [ Time Frame: 10 minutes ]
    Immediately after supplement ingestion and lunch consumption

  2. Consumption time for PKU supplements/foods [ Time Frame: 20 minutes ]
    Maximum 5 minutes for supplement ingestion and maximum 20 minutes for lunch consumption



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440932


Locations
United Kingdom
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Dalia Malkova, Senior Lecturer, University of Glasgow
ClinicalTrials.gov Identifier: NCT02440932     History of Changes
Other Study ID Numbers: 200130139
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016

Keywords provided by Dr Dalia Malkova, University of Glasgow:
low Phenylalanine diet
PKU supplements
diet induced thermogenesis
appetite
body weight

Additional relevant MeSH terms:
Phenylketonurias
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs