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

NCT02440932 | Completed

• 1 other identifier: 200130139
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Phenylketonuria (PKU)

Keywords

low Phenylalanine diet; PKU supplements; diet induced thermogenesis; appetite; body weight

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• Subjective appetite score

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

  300 minutes

• 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

Secondary Outcomes (2)

• Taste perception of PKU supplements/foods

  10 minutes

• Consumption time for PKU supplements/foods

  20 minutes

Study Arms (2)

Phenylketonuria-type diet

EXPERIMENTAL

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; Other: Normal (control) diet

Normal diet

OTHER

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; Other: Normal (control) diet

Interventions

Phenylketonuria-type diet DIETARY_SUPPLEMENT

Breakfast, lunch and open buffet dinner

Normal diet; Phenylketonuria-type diet

Normal (control) diet OTHER

Breakfast, lunch and open buffet dinner

Normal diet; Phenylketonuria-type diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult
• Body weight stable for previous 4 months
• Regular menstrual cycle (females)

You may not qualify if:

• Pregnancy or lactation (females)
• History of eating disorder
• History of gastrointestinal problems or surgery
• History of allergy
• History of chronic illness
• On any medication
• Smoking
• On nutritional supplements
• Following specific diet
• Currently taking part in other research

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

Human Nutrition, School of Medicine, University of Glasgow

Glasgow, G31 2ER, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28318688 DERIVED

MeSH Terms

Conditions

Phenylketonurias; Body Weight

Interventions

Diet

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Dalia Malkova, PhD

  University of Glasgow

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 12, 2015
• Study Start: November 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 23, 2016

Record last verified: 2016-05

Locations

GB (1)