HealthyNCT05113914
The Age-related Changes of Energy Metabolism in Physically Fit Adult Males
A study testing Cardio-pulmonary exercise test in people with Healthy, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The influence of age and physical fitness level on the level of energy metabolism and antioxidant capacity in adult males. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cardio-pulmonary exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2011to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
- non-smoking
- physically fit, including top-level athletes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Age and Physical Fitness Level on the Level of Energy Metabolism and Antioxidant Capacity in Adult Males
The influence of age and physical fitness level on the level of energy metabolism and antioxidant capacity in adult males.
Read the detailed description
Over four hundred healthy, adult males of different age categories and physical fitness levels were included in the study. There is much research convincing that in athletes of various sports disciplines the level of energy metabolism, oxidative stress, and amino acid profiles during years of training undergoes sports adaptation. The study aimed to evaluate how age and physical fitness level affects the level of purine metabolites and metabolites of nicotinamide adenine dinucleotide, the level of antioxidant capacity, and amino acid profiles. Investigators hypothesized that there will be an age-related decline in most of the physiological indices, but significant differences will appear regarding the level of an individual's sports adaptation.
- Conditions
- Healthy
- Being tested
- Cardio-pulmonary exercise test
- Keywords
- athletes, masters, purine metabolites, NAD metabolites, CPET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio-pulmonary exercise testDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy, physically fit men | Experimental | All participants underwent a single CPET test with pre- and post-exercise blood measurements. Receives: Diagnostic Test: Cardio-pulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardio-respiratory measures
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.
Measured: during the intervention
Secondary outcomes (12)
Blood Lactate level
Lactate concentration was performed by the spectrophotometric enzymatic method.
Measured: baseline and immediately after the intervention
Plasma purine nucleotides
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)].
Measured: baseline and immediately after the intervention
Erythrocyte Purine Metabolites
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)].
Measured: baseline and immediately after the intervention
Hypoxanthine-guanine phosphoribosyltransferase (HGPRT) activity
The HGPRT activity was estimated in whole blood and in erythrocytes using high-performance liquid chromatography (HPLC) with UV-VIS detection.
Measured: baseline and immediately after the intervention
Nicotinamide Adenine Dinucleotide (NAD) and its metabolites
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)
Measured: baseline and immediately after the intervention
Total antioxidant status (TAS)
Total antioxidant status (TAS) measurement was performed using commercially available ELISA immunoassay.
Measured: baseline
Thiobarbituric-acid-reactive substances (TBARS)
The measurement of thiobarbituric-acid-reactive substances (TBARS) was performed using commercially available ELISA immunoassay.
Measured: baseline
Malondialdehyde (MDA)
The measurement of malondialdehyde (MDA) was performed using commercially available ELISA immunoassay.
Measured: baseline
Polyphenols
The measurement of polyphenols was performed using commercially available ELISA immunoassay.
Measured: baseline
Reduced glutathione (GSH)
The measurement of reduced glutathione (GSH) was performed using commercially available ELISA immunoassay.
Measured: baseline
Glutathione peroxidase (GPx) activity
The measurement of glutathione peroxidase (GPx) activity was performed using commercially available ELISA immunoassay.
Measured: baseline
Aminoacid profile
The levels of 20 aminoacids were estimated in plasma using mass spectrometric procedure.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Jan 2011
- Primary completion30 Nov 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacek Zieliński, Prof., Principal investigator, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113914
- Sponsor's protocol ID
- AWF_LA_MA865862
- Status last verified
- Sep 2021
- First submitted
- 7 Oct 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pospieszna B, Kusy K, Slominska EM, Zielinski J, Ciekot-Soltysiak M. Erythrocyte nicotinamide adenine dinucleotide concentration is enhanced by systematic sports participation. BMC Sports Sci Med Rehabil. 2024 Oct 15;16(1):216. doi: 10.1186/s13102-024-00999-y.
PubMed 39407226
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Age and Physical Fitness Level on the Level of Energy Metabolism and Antioxidant Capacity in Adult Males
- ClinicalTrials.gov ID
- NCT05113914
- Acronym / sponsor ID
- AWF_LA_MA865862
- Conditions
- Healthy
- Keywords
- athletes, masters, purine metabolites, NAD metabolites, CPET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The influence of age and physical fitness level on the level of energy metabolism and antioxidant capacity in adult males.
Detailed description
Over four hundred healthy, adult males of different age categories and physical fitness levels were included in the study. There is much research convincing that in athletes of various sports disciplines the level of energy metabolism, oxidative stress, and amino acid profiles during years of training undergoes sports adaptation. The study aimed to evaluate how age and physical fitness level affects the level of purine metabolites and metabolites of nicotinamide adenine dinucleotide, the level of antioxidant capacity, and amino acid profiles. Investigators hypothesized that there will be an age-related decline in most of the physiological indices, but significant differences will appear regarding the level of an individual's sports adaptation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy, physically fit men | Experimental | Diagnostic Test: Cardio-pulmonary exercise testAll participants underwent a single CPET test with pre- and post-exercise blood measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy
- non-smoking
- physically fit, including top-level athletes
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardio-pulmonary exercise testAn 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. | Diagnostic test | Healthy, physically fit men |
Primary outcome
Cardio-respiratory measures
Time frame: during the intervention
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.
12 secondary outcomes
Blood Lactate level
Time frame: baseline and immediately after the intervention
Plasma purine nucleotides
Time frame: baseline and immediately after the intervention
Erythrocyte Purine Metabolites
Time frame: baseline and immediately after the intervention
Hypoxanthine-guanine phosphoribosyltransferase (HGPRT) activity
Time frame: baseline and immediately after the intervention
Nicotinamide Adenine Dinucleotide (NAD) and its metabolites
Time frame: baseline and immediately after the intervention
Total antioxidant status (TAS)
Time frame: baseline
Thiobarbituric-acid-reactive substances (TBARS)
Time frame: baseline
Malondialdehyde (MDA)
Time frame: baseline
Polyphenols
Time frame: baseline
Reduced glutathione (GSH)
Time frame: baseline
Glutathione peroxidase (GPx) activity
Time frame: baseline
Aminoacid profile
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Derived from this study: PubMed 39407226Pospieszna B, Kusy K, Slominska EM, Zielinski J, Ciekot-Soltysiak M. Erythrocyte nicotinamide adenine dinucleotide concentration is enhanced by systematic sports participation. BMC Sports Sci Med Rehabil. 2024 Oct 15;16(1):216. doi: 10.1186/s13102-024-00999-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacek Zieliński, Prof. principal investigator
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardio-pulmonary exercise test in people with Healthy, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardio-respiratory measures (time frame: during the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05113914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.