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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05113914
Other study ID # AWF_LA_MA865862
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2011
Est. completion date December 20, 2019

Study information

Verified date September 2021
Source Poznan University of Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The influence of age and physical fitness level on the level of energy metabolism and antioxidant capacity in adult males.


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.


Recruitment information / eligibility

Status Completed
Enrollment 420
Est. completion date December 20, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Poland Poznan University of Physical Education Poznan

Sponsors (1)

Lead Sponsor Collaborator
Poznan University of Physical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. during the intervention
Secondary Blood Lactate level Lactate concentration was performed by the spectrophotometric enzymatic method. baseline and immediately after the intervention
Secondary 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)].
baseline and immediately after the intervention
Secondary 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)].
baseline and immediately after the intervention
Secondary 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. baseline and immediately after the intervention
Secondary 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)
baseline and immediately after the intervention
Secondary Total antioxidant status (TAS) Total antioxidant status (TAS) measurement was performed using commercially available ELISA immunoassay. baseline
Secondary Thiobarbituric-acid-reactive substances (TBARS) The measurement of thiobarbituric-acid-reactive substances (TBARS) was performed using commercially available ELISA immunoassay. baseline
Secondary Malondialdehyde (MDA) The measurement of malondialdehyde (MDA) was performed using commercially available ELISA immunoassay. baseline
Secondary Polyphenols The measurement of polyphenols was performed using commercially available ELISA immunoassay. baseline
Secondary Reduced glutathione (GSH) The measurement of reduced glutathione (GSH) was performed using commercially available ELISA immunoassay. baseline
Secondary Glutathione peroxidase (GPx) activity The measurement of glutathione peroxidase (GPx) activity was performed using commercially available ELISA immunoassay. baseline
Secondary Aminoacid profile The levels of 20 aminoacids were estimated in plasma using mass spectrometric procedure. baseline
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