NCT07526909 Effect of Different Meal Types Given Before Exercise on Plasma Amino Acid Levels and Metabolic Control Parameters in Classical Phenylketonuria Patients Undergoing Aerobic and Resistance Exercises
| NCT ID | NCT07526909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hacettepe University |
| Condition | Phenylketonuria |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-10-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will be the first in the literature to evaluate the relationship between aerobic and resistance exercises, plasma amino acid levels, metabolic control of patients, and the metabolic response to exercise with different types of meals in patients with Phenylketonuria (PKU). In patients with phenylketonuria, the aim is to determine which pre-exercise dietary recommendations are more physiologically appropriate and ideal for achieving good metabolic control. In the literature, there are very few studies examining the effects of exercise on plasma amino acid levels and metabolic parameters in PKU patients.
Eligibility Criteria
Inclusion Criteria: * Be over 18 years old, * Having a classic FKU diagnosis, * Not being actively engaged in sports, * Not having any other existing diseases, * Not having an active infection, * Have a BMI in the range of 20-28 kg/m2 within the last 3 months, * Agreeing to consume test meals and provide blood samples for parameters that will evaluate plasma amino acid levels as part of the research * Being willing to participate in this study Exclusion Criteria: * Presence of a chronic disease accompanying FKU disease (endocrine, etc.) * The individual with FKU has mental retardation or is deemed unfit for work based on psychomotor assessment, * Recent weight loss, history of hospitalisation, a past infection, or a diagnosed illness * Use of drugs or alcohol that alter protein and energy metabolism (e.g., corticosteroids, etc.) * Pregnancy status * Smoking habits The considerations to be taken into account when planning the day/date of the test are as follows. * Having engaged in heavy exercise or sports within 24 hours before the application of test diets, * Being in the menstrual period for female patients.
Contact & Investigator
SERAP SIVRI, Professor, MD
PRINCIPAL INVESTIGATOR
Hacettepe University
Frequently Asked Questions
Who can join the NCT07526909 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Phenylketonuria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07526909 currently recruiting?
Yes, NCT07526909 is actively recruiting participants. Contact the research team at damla.yildirim@hacettepe.edu.tr for enrollment information.
Where is the NCT07526909 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07526909 clinical trial?
NCT07526909 is sponsored by Hacettepe University. The principal investigator is SERAP SIVRI, Professor, MD at Hacettepe University. The trial plans to enroll 10 participants.