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

U

University of Glasgow

Status

Completed

Conditions

Phenylketonuria (PKU)

Treatments

Dietary Supplement: Phenylketonuria-type diet
Other: Normal (control) diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02440932
200130139

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

26 participants in 2 patient groups

Phenylketonuria-type diet
Experimental group
Description:
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
Treatment:
Other: Normal (control) diet
Dietary Supplement: Phenylketonuria-type diet
Normal diet
Other group
Description:
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
Treatment:
Other: Normal (control) diet
Dietary Supplement: Phenylketonuria-type diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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