- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05113914
The Age-related Changes of Energy Metabolism in Physically Fit Adult Males
The Influence of Age and Physical Fitness Level on the Level of Energy Metabolism and Antioxidant Capacity in Adult Males
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Poznań, Poland, 61-871
- Poznań University of Physical Education
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy
- non-smoking
- physically fit, including top-level athletes
Exclusion Criteria:
- no reported history of a cardiopulmonary or renal diseases, and other chronic diseases
- no major orthopedic injury or illness resulting in an inability to run
- no medications that could affect cardiopulmonary functions
- normal resting electrocardiogram
- body mass index (BMI) below 30.0 kg·m-2
- normal erythrocyte count and Hb content
- no pathological states known of significantly elevated adenylate pool and concentration of ATP, e.g. sickle cell disease, diabetes, leukemia, sepsis, tuberculosis, meningococcal infection, or renal insufficiency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Healthy, physically fit men
All participants underwent a single CPET test with pre- and post-exercise blood measurements.
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An incremental running test was conducted on the treadmill.
Initially, the exercise protocol included standing still for 3 min and walking for 3 min at a constant speed of 4 km/h.
After this introductory part, the speed was increased to 8 km/h and then every 3 min by 2 km/h until the volitional exhaustion was reached.
During all procedure oxygen consumption was measured with the use of a portable breath-by-breath ergospirometer.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cardio-respiratory measures
Time Frame: during the intervention
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Cardiopulmonary exercise test (CPET) was conducted while an incremental running test on the treadmill using a portable breath-by-breath ergospirometer and heart rate monitor.
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during the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood Lactate level
Time Frame: baseline and immediately after the intervention
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Lactate concentration was performed by the spectrophotometric enzymatic method.
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baseline and immediately after the intervention
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Plasma purine nucleotides
Time Frame: baseline and immediately after the intervention
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The plasma purine metabolites were estimated in plasma using high-performance liquid chromatography (HPLC) with UV-VIS detection. Measurements performed: Guanosine, Inosine, Adenosine, Hypoxanthine, Xanthine, Uric Acid, Allantoin, Adenine Nucleotides [adenosine triphosphate (ATP), adenosine diphosphate (ADP), adenosine monophosphate (AMP), inosine monophasphate (IMP)], Guanine Nucleotides [guanosine triphosphate (GTP), guanosine diphosphate (GDP), guanosine monophosphate (GMP)]. |
baseline and immediately after the intervention
|
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Erythrocyte Purine Metabolites
Time Frame: baseline and immediately after the intervention
|
The erythrocyte purine metabolites were estimated in erythrocytes using high-performance liquid chromatography (HPLC) with UV-VIS detection. Measurements performed: Adenine Nucleotides [adenosine triphosphate (ATP), adenosine diphosphate (ADP), adenosine monophosphate (AMP), inosine monophasphate (IMP)], Guanine Nucleotides [guanosine triphosphate (GTP), guanosine diphosphate (GDP), guanosine monophosphate (GMP)]. |
baseline and immediately after the intervention
|
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Hypoxanthine-guanine phosphoribosyltransferase (HGPRT) activity
Time Frame: baseline and immediately after the intervention
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The HGPRT activity was estimated in whole blood and in erythrocytes using high-performance liquid chromatography (HPLC) with UV-VIS detection.
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baseline and immediately after the intervention
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Nicotinamide Adenine Dinucleotide (NAD) and its metabolites
Time Frame: baseline and immediately after the intervention
|
Nicotinamide Adenine Dinucleotide (NAD) and its metabolites were estimated in plasma using mass spectrometric procedure. Measurements performed: Nicotinamide Adenine Dinucleotide (NAD+), Nicotinamide (NA), 1-Methylnicotinamide (MNA), 1-methyl-2-pyridone-5-carboxamide (M2PY), 1-methyl-4-pyridone-5-carboxamide (M4PY), Nicotinamide Mononucleotide (NMN), 4-pyridone-3-carboxamide ribonucleoside (4PYR) |
baseline and immediately after the intervention
|
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Total antioxidant status (TAS)
Time Frame: baseline
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Total antioxidant status (TAS) measurement was performed using commercially available ELISA immunoassay.
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baseline
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Thiobarbituric-acid-reactive substances (TBARS)
Time Frame: baseline
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The measurement of thiobarbituric-acid-reactive substances (TBARS) was performed using commercially available ELISA immunoassay.
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baseline
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Malondialdehyde (MDA)
Time Frame: baseline
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The measurement of malondialdehyde (MDA) was performed using commercially available ELISA immunoassay.
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baseline
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Polyphenols
Time Frame: baseline
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The measurement of polyphenols was performed using commercially available ELISA immunoassay.
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baseline
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Reduced glutathione (GSH)
Time Frame: baseline
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The measurement of reduced glutathione (GSH) was performed using commercially available ELISA immunoassay.
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baseline
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Glutathione peroxidase (GPx) activity
Time Frame: baseline
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The measurement of glutathione peroxidase (GPx) activity was performed using commercially available ELISA immunoassay.
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baseline
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Aminoacid profile
Time Frame: baseline
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The levels of 20 aminoacids were estimated in plasma using mass spectrometric procedure.
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baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Jacek Zieliński, Prof., Poznań University of Physical Education
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AWF_LA_MA865862
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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