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

Sponsor
Hacettepe University
Study ID
NCT07526909
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aerobic Exercise — BEHAVIORAL
    Participants performed 30 minutes of moderate-intensity aerobic exercise on a treadmill at 80% of maximum heart rate with a 3% incline.
  • Resistance Exercise — BEHAVIORAL
    Participants performed a resistance exercise session including 3 sets of 10 repetitions of crunch, push-up, forward lunge, and squat exercises.
  • Water — OTHER
    Participants consumed 200 ml of water prior to the exercise session.
  • Carbohydrates — DIETARY_SUPPLEMENT
    Participants consumed carbohydrates at a dose of 1 g/kg/hour prior to the exercise session.
  • Protein — DIETARY_SUPPLEMENT
    Participants consumed protein equivalent to 0.4 g/kg/hour (amino acids) prior to the exercise session.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Mar 2026
Primary completion
May 31, 2026
Completion
Jul 15, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Aerobic Exercise + Water
    Participants performed aerobic exercise after consuming only water.
  • Experimental: Aerobic Exercise + Carbohydrates
    Participants performed aerobic exercise after consuming carbohydrates with water.
  • Experimental: Aerobic Exercise + Carbohydrates + Protein
    Participants performed aerobic exercise after consuming carbohydrates and protein with water.
  • Experimental: Resistance Exercise + Water
    Participants performed resistance exercise after consuming only water.
  • Experimental: Resistance Exercise + Carbohydrates
    Participants performed resistance exercise after consuming carbohydrates with water.
  • Experimental: Resistance Exercise + Carbohydrates + Protein
    Participants performed resistance exercise after consuming carbohydrates and protein with water.

Primary Outcome Measure

Change in Plasma Phenylalanine Levels [ Time Frame: Baseline, pre-exercise, and post-exercise (0, 30, 60, 90, and 120 minutes) ]

Central Contacts

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