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

NCT07526909 | Recruiting

• 1 other identifier: 23-AKD-64
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Phenylketonuria

Keywords

Phenylketonuria; Phenylalanine; Low-protein diet; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in Plasma Phenylalanine Levels

  Venous blood samples will be analyzed to determine changes in plasma phenylalanine concentrations in response to exercise and different pre-exercise meal types.

  Baseline, pre-exercise, and post-exercise (0, 30, 60, 90, and 120 minutes)

Secondary Outcomes (13)

• Change in Plasma Tyrosine Levels

  Baseline, pre-exercise, and post-exercise (0, 30, 60, 90, and 120 minutes)

• Change in Plasma Leucine Levels

  Baseline, pre-exercise, and post-exercise (0, 30, 60, 90, and 120 minutes)

• Change in Plasma Isoleucine Levels

  Baseline, pre-exercise, and post-exercise (0, 30, 60, 90, and 120 minutes)

• Change in Plasma Valine Levels

  Baseline, pre-exercise, and post-exercise (0, 30, 60, 90, and 120 minutes)

• Change in Plasma Methionine Levels

  Baseline, pre-exercise, and post-exercise (0, 30, 60, 90, and 120 minutes)

Study Arms (6)

Aerobic Exercise + Water

EXPERIMENTAL

Participants performed aerobic exercise after consuming only water.

Behavioral: Aerobic Exercise; Other: Water

Aerobic Exercise + Carbohydrates

EXPERIMENTAL

Participants performed aerobic exercise after consuming carbohydrates with water.

Behavioral: Aerobic Exercise; Other: Water; Dietary Supplement: Carbohydrates

Aerobic Exercise + Carbohydrates + Protein

EXPERIMENTAL

Participants performed aerobic exercise after consuming carbohydrates and protein with water.

Behavioral: Aerobic Exercise; Other: Water; Dietary Supplement: Carbohydrates; Dietary Supplement: Protein

Resistance Exercise + Water

EXPERIMENTAL

Participants performed resistance exercise after consuming only water.

Behavioral: Resistance Exercise; Other: Water

Resistance Exercise + Carbohydrates

EXPERIMENTAL

Participants performed resistance exercise after consuming carbohydrates with water.

Behavioral: Resistance Exercise; Other: Water; Dietary Supplement: Carbohydrates

Resistance Exercise + Carbohydrates + Protein

EXPERIMENTAL

Participants performed resistance exercise after consuming carbohydrates and protein with water.

Behavioral: Resistance Exercise; Other: Water; Dietary Supplement: Carbohydrates; Dietary Supplement: Protein

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.

Aerobic Exercise + Carbohydrates; Aerobic Exercise + Carbohydrates + Protein; Aerobic Exercise + Water

Resistance Exercise BEHAVIORAL

Participants performed a resistance exercise session including 3 sets of 10 repetitions of crunch, push-up, forward lunge, and squat exercises.

Resistance Exercise + Carbohydrates; Resistance Exercise + Carbohydrates + Protein; Resistance Exercise + Water

Water OTHER

Participants consumed 200 ml of water prior to the exercise session.

Aerobic Exercise + Carbohydrates; Aerobic Exercise + Carbohydrates + Protein; Aerobic Exercise + Water; Resistance Exercise + Carbohydrates; Resistance Exercise + Carbohydrates + Protein; Resistance Exercise + Water

Carbohydrates DIETARY_SUPPLEMENT

Participants consumed carbohydrates at a dose of 1 g/kg/hour prior to the exercise session.

Aerobic Exercise + Carbohydrates; Aerobic Exercise + Carbohydrates + Protein; Resistance Exercise + Carbohydrates; Resistance Exercise + Carbohydrates + Protein

Protein DIETARY_SUPPLEMENT

Participants consumed protein equivalent to 0.4 g/kg/hour (amino acids) prior to the exercise session.

Aerobic Exercise + Carbohydrates + Protein; Resistance Exercise + Carbohydrates + Protein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Phenylketonurias; Motor Activity

Interventions

Exercise; Resistance Training; Water; Carbohydrates; Proteins

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; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Amino Acids, Peptides, and Proteins

Study Officials

• SERAP SIVRI, Professor, MD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DAMLA KALKAN, MSc, PhD(c)

CONTACT

+905543528779; damla.yildirim@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, Dietition

Model Details: Two different exercises with three different diets, a total of six models in a crossover study.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 14, 2026
• Study Start: October 1, 2025
• Primary Completion: May 31, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)