The Age-related Changes of Energy Metabolism in Physically Fit Adult Males

November 10, 2021 updated by: Poznan University of Physical Education

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Poznań, Poland, 61-871
        • Poznań University of Physical Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. healthy
  2. non-smoking
  3. physically fit, including top-level athletes

Exclusion Criteria:

  1. no reported history of a cardiopulmonary or renal diseases, and other chronic diseases
  2. no major orthopedic injury or illness resulting in an inability to run
  3. no medications that could affect cardiopulmonary functions
  4. normal resting electrocardiogram
  5. body mass index (BMI) below 30.0 kg·m-2
  6. normal erythrocyte count and Hb content
  7. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Healthy, physically fit men
All participants underwent a single CPET test with pre- and post-exercise blood measurements.
Diagnostic test: Cardio-pulmonary exercise 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
during the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Lactate level
Time Frame: baseline and immediately after the intervention
Lactate concentration was performed by the spectrophotometric enzymatic method.
baseline and immediately after the intervention
Plasma purine nucleotides
Time Frame: baseline and immediately after the intervention

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
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
Hypoxanthine-guanine phosphoribosyltransferase (HGPRT) activity
Time Frame: baseline and immediately after the intervention
The HGPRT activity was estimated in whole blood and in erythrocytes using high-performance liquid chromatography (HPLC) with UV-VIS detection.
baseline and immediately after the intervention
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
Total antioxidant status (TAS)
Time Frame: baseline
Total antioxidant status (TAS) measurement was performed using commercially available ELISA immunoassay.
baseline
Thiobarbituric-acid-reactive substances (TBARS)
Time Frame: baseline
The measurement of thiobarbituric-acid-reactive substances (TBARS) was performed using commercially available ELISA immunoassay.
baseline
Malondialdehyde (MDA)
Time Frame: baseline
The measurement of malondialdehyde (MDA) was performed using commercially available ELISA immunoassay.
baseline
Polyphenols
Time Frame: baseline
The measurement of polyphenols was performed using commercially available ELISA immunoassay.
baseline
Reduced glutathione (GSH)
Time Frame: baseline
The measurement of reduced glutathione (GSH) was performed using commercially available ELISA immunoassay.
baseline
Glutathione peroxidase (GPx) activity
Time Frame: baseline
The measurement of glutathione peroxidase (GPx) activity was performed using commercially available ELISA immunoassay.
baseline
Aminoacid profile
Time Frame: baseline
The levels of 20 aminoacids were estimated in plasma using mass spectrometric procedure.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Physical Education

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacek Zieliński, Prof., Poznań University of Physical Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AWF_LA_MA865862

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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