Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07526909

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

Led by Hacettepe University · Updated on 2026-04-16

10

Participants Needed

1

Research Sites

6 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying adults with classical Phenylketonuria (PKU) to understand how different types of meals before exercise affect plasma amino acid levels and metabolic control. This study aims to find the best dietary recommendations before aerobic and resistance exercises for patients with PKU, a rare metabolic disorder. It is the first study to evaluate these effects in detail, including hormonal responses and metabolic parameters during exercise. Participants will consume one of three test diets: water only, carbohydrates only, or a mixture of amino acids and carbohydrates. They will perform 30 minutes of either aerobic exercise on a treadmill or resistance exercises including crunches, push-ups, lunges, and squats. Each participant will complete six exercise sessions over six weeks with one week between sessions, alternating the type of exercise and pre-exercise meal. The study uses a randomized design and closely monitors the effects of these meals and exercises. Throughout the study, blood samples will be collected before, during, and after exercise to measure plasma amino acids such as phenylalanine, tyrosine, and branched-chain amino acids, along with glucose, insulin, lactate, blood urea nitrogen, and creatinine levels. Assessments include an initial EKG and exercise conditioning evaluation. Participants will visit the hospital on six different days, each separated by a week, for these measurements. The study's primary outcome is the change in plasma phenylalanine levels, with several other metabolic parameters measured as secondary outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be over 18 years old
  • Have a diagnosis of classic Phenylketonuria (PKU)
  • Not actively engaged in sports
  • Have no other existing diseases
  • Have no active infections
  • Have a Body Mass Index (BMI) between 20 and 28 kg/m2 within the last 3 months
  • Agree to consume test meals and provide blood samples for plasma amino acid evaluation
  • Willing to participate in the study
Not Eligible

You will not qualify if you...

  • Have a chronic disease accompanying PKU (such as endocrine disorders)
  • Have mental retardation or be deemed unfit for work based on psychomotor assessment
  • Recent weight loss, history of hospitalization, past infection, or diagnosed illness
  • Use drugs or alcohol that affect protein and energy metabolism (e.g., corticosteroids)
  • Pregnant
  • Smoking habit
  • Engaged in heavy exercise or sports within 24 hours before test diets
  • For female patients, being in the menstrual period on test days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Exercise Sessions with Test Meals

Duration - 6 weeks with one-week intervals between sessions

Participants attend six sessions over six weeks where they consume different test meals (water only, carbohydrates only, carbohydrates plus protein) before performing either aerobic or resistance exercise. Blood samples are taken before and at intervals after exercise to monitor plasma amino acid and metabolic parameters.

6 visits (in-person), one visit per week

Trial Site Locations

Total: 1 location

1

Hacettepe University

Ankara, Ankara, Turkey (Türkiye), 06100

Actively Recruiting

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Research Team

D

DAMLA KALKAN, MSc, PhD(c)

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

6

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