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

NCT ID: NCT02440932

Last Updated: 2016-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Phenylketonuria (PKU)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Phenylketonuria-type diet

Intervention Type DIETARY_SUPPLEMENT

Breakfast, lunch and open buffet dinner

Normal (control) diet

Intervention Type OTHER

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

Group Type OTHER

Phenylketonuria-type diet

Intervention Type DIETARY_SUPPLEMENT

Breakfast, lunch and open buffet dinner

Normal (control) diet

Intervention Type OTHER

Breakfast, lunch and open buffet dinner

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phenylketonuria-type diet

Breakfast, lunch and open buffet dinner

Intervention Type DIETARY_SUPPLEMENT

Normal (control) diet

Breakfast, lunch and open buffet dinner

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Glasgow

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Dalia Malkova

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dalia Malkova, PhD

Role: STUDY_CHAIR

University of Glasgow

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Human Nutrition, School of Medicine, University of Glasgow

Glasgow, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28318688 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

200130139

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.