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LactatePROTEOMETNCT06365320

Association Between Training Load and Lactate and Other Metabolites Analyzed by Metabolomic and Proteomic Techniques

A study testing Single basketball training in people with Lactate and Sports Performance, run by Fundació Eurecat at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Physical exercise induces numerous changes in the body in a complex signalling network caused by or in response to increased metabolic activity of contracting skeletal muscles. The application of omics analytical techniques such as proteomics and metabolomics in the field of sport allows us to understand how the human… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Lactate, Sports Performance, Metabolomics
What is being tested?
Single basketball training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesSpain
Study dates
4 Oct 2024to 1 Apr 2025
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 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Men and women, active players of the Catalan Basketball Federation and the Spanish Basketball Federation between 18 and 40 years old (both included).
  • Sign the informed consent.

Who cannot join

  • Present any metabolic disorder that may interfere with the objectives of the study (high blood pressure, diabetes, hypercholesterolemia or obesity; Body Mass Index (BMI) values ≥ 35 Kg/m2.
  • Suffer from disorders of glucose metabolism that may alter lactate synthesis, such as lactic acidosis, hyperlactatemia, or other metabolic acidosis.
  • Taking any type of medication that may alter metabolite or lactate levels.
  • Having belonephobia (phobia of needles).
  • Take ergogenic aids or supplements based on sucrose or glucose polymers before, during, or after training.
  • Being a smoker.
  • Being pregnant.
  • Breastfeeding.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites
  • Fundació Eurecat, Center for Omic Sciences

    Reus, Tarragona, 43204

  • Fundació Eurecat

    Reus, Tarragona, 43204

Other trials in Spain

About this study

Official title: Evaluation of the Relationship Between Training Load and the Levels of Lactate and Other Metabolites Analyzed in Blood and Saliva Samples Using Metabolomic and Proteomic Techniques in Federated Basketball Players: Quasi-experimental Study

Physical exercise induces numerous changes in the body in a complex signalling network caused by or in response to increased metabolic activity of contracting skeletal muscles.

The application of omics analytical techniques such as proteomics and metabolomics in the field of sport allows us to understand how the human body responds to exercise and how sports results can be improved by optimising nutrition and training. Both omics techniques offer a quantitative measurement of the metabolic profiles associated with exercise and are able to identify metabolic signatures of athletes from different sports disciplines.

Read more

Basketball is a high-intensity exercise modality interspersed with low-intensity. The performance requirements of basketball include aerobic and anaerobic metabolism, with anaerobic metabolism being considered the main energy system. Therefore, basketball players need great athletic ability to produce a successful performance during competition.

For optimal sports performance it is important to adjust the training load, i.e. the degree of effort that the player can withstand in a single training session. Coaches require effective and objective load monitoring tools that allow them to make decisions about training plans based on the needs of each player.

Microsampling systems emerge as an alternative to venipuncture by facilitating self-sampling, which can be carried out outside healthcare centres, in a comfortable and precise way from a small finger prick that the user can perform. These systems are less expensive and can be effective in measuring the levels of glucose metabolism products, such as lactate, through the application of metabolomics and proteomics. On the other hand, the use of non-invasive methods of measuring lactate levels is becoming increasingly popular in sports medicine. The use of saliva as an alternative fluid to the blood shows promise for identifying the concentrations of metabolites that occur during and after sports training.

Read the detailed description

The study hypothesizes that the use of minimally invasive microsampling systems, and subsequent application of metabolomics and proteomics, will allow the detection of differences in the levels of lactate and other metabolites and proteins produced by the greater energy demand of the musculoskeletal system after a single collective training on the court, in federated basketball players. In addition, lactate levels will be correlated with the subjective sensation of perceived exertion.

The main objective of the study is to apply metabolomics techniques to analyze lactate levels in capillary blood samples collected by a dried blood spot (DBS) microsampling device, and to study their correlation with the subjective sensation of perceived effort in federated basketball players before and after performing a single collective training session on the court.

The secondary objectives of the study are to measure the change in lactate levels in capillary blood samples collected by a DBS device, and in saliva samples collected by a collector, before and after performing a single collective training on the court. In addition, in these samples, the change in the levels of other metabolomic and proteomic markers related to energy, lipid and amino acid metabolism will be measured. The correlation between salivary and blood lactate levels will also be studied; subjective sensation of perceived exertion and salivary lactate levels; the subjective sensation of perceived exertion and the levels of other metabolomic and proteomic markers will be also studied.

A single-group quasi-experimental (or pre-post) study will be carried out on 70 basketball players between the ages of 18 and 40.

Each participant will attend 2 visits to the sports facilities of their basketball club:

  • A recruitment and pre-selection visit (to check the eligibility criteria and sign the informed consent). If the inclusion criteria are met, will be scheduled to:
  • A single study visit on the same day agreed for training.

The main variable of the study is the correlation between lactate levels, measured in capillary blood pre- and post-training, and the subjective sensation of perceived effort.

Being tested
Single basketball training
Keywords
Physical training, Lactate, Dried Blood Spot Method, Basketball

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single basketball trainingOther

    Single basketball training session with fixed intensity and duration

Study groups in NCT06365320
Study groupRoleWhat they receive
Pre-test and post-test measurementsExperimentalBefore and after a single collective training on the court. Collection of capillary blood and saliva samples; Completion of lifestyle questionnaires and sociodemographic and clinical factors; Anthropometric measurements.
Receives: Other: Single basketball training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between blood lactate levels and the subjective sensation of perceived effort

    Lactate concentration (μM) measured in capillary blood pre- and post- training. Four drops of capillary blood will be collected pre- and post-training by means of a puncture with a retractable lancet on the index, middle or ring finger, and deposited on a dried blood spot (DBS) "HemaXis DB10" card for analysis.

    The subjective sensation of perceived effort will be assessed with the Perceived Exertion Index (RPE) measured post-training. This tool is used to monitor perceived effort during sports practice. It consists of a graduated scale from 0 to 10 where 0 is rest and 10 is maximum perceived effort.

    Measured: Pre-training (baseline) and post-training (immediately after the training)

Secondary outcomes (25)
  1. Change in saliva lactate levels

    A 15 mL Falcon tube will be used to collect the saliva sample by passive salivation. The lactate concentration in saliva will be analysed using the GC-qTOF technique.

    Measured: Pre-training (baseline) and post-training (immediately after the training)

  2. Change in blood lactate levels

    Lactate concentration (μM) measured in capillary blood collected in a dried blood spot card (DBS). The dried blood samples will be shipped to the analytical laboratory and analysed using combined analysis of liquid chromatography (UHPLC) coupled to triple quadrupole mass spectrometry (QqQ/MS) or quadrupole-time-of-flight mass spectrometry (qTOF/MS).

    Measured: Pre-training (baseline) and post-training (immediately after the training)

  3. Change in levels of lipid metabolic markers determined in capillary blood samples

    Lipid metabolic marker levels (described below) will be measured in capillary blood samples using the same DBS device as in the case of the primary outcome. Liquid chromatography (UHPLC 1290 Infinity II Series, Agilent Technologies) coupled to quadrupole - time of flight mass spectrometry (qTOF/MS 6546 Series, Agilent Technologies) will be used as metabolomic techniques.

    Measured lipids: phosphatidylcholines, lysophosphatidylcholines, sphingomyelins, diglycerides, triglycerides, cholesterol esters, phosphatidylethanolamine and lysophosphatidylethanolamines.

    All lipid metabolic markers in capillary bood will be reported in micromol (µM).

    Measured: Pre-training (baseline) and post-training (immediately after the training)

  4. Change in levels of other lipid metabolic markers determined in capillary blood samples

    Lipid metabolic marker levels (described below) will be measured in capillary blood samples using the same DBS device as in the case of the primary outcome. Liquid chromatography (UHPLC 1290 Infinity II Series, Agilent Technologies) coupled to triple quadrupole mass spectrometry (QqQ/MS 6490 Series, Agilent Technologies) will be used as metabolomic techniques.

    Measured lipids: oxylipins, non-esterified fatty acids, hormones, and acetylcarnitines.

    All lipid metabolic markers in capillary blood will be reported in micromol (µM).

    Measured: Pre-training (baseline) and post-training (immediately after the training)

  5. Change in levels of polar metabolites determined in capillary blood samples

    Polar metabolites (described below) will be measured in capillary blood samples using the same DBS device as in the case of the primary outcome. Gas chromatography coupled to quadrupole - time of flight mass spectrometry (GC-qTOF 7200 Series, Agilent Technologies) will be used as metabolomic techniques.

    Measured polar metabolites: organic acids, amino acids, compounds related to energy metabolism and sugars.

    All polar metabolites in capillary blood will be reported in micromol (µM).

    Measured: Pre-training (baseline) and post-training (immediately after the training)

  6. Change in levels of lipid metabolic markers determined in saliva samples

    Lipid metabolic markers (described below) will be measured in saliva samples using a collection tube (15 mL Falcon tube). Gas chromatography coupled to quadrupole - time of flight mass spectrometry (GC-qTOF 7200 Series, Agilent Technologies) will be used as metabolomic techniques.

    Measured lipids: phosphatidylcholines, lysophosphatidylcholines, sphingomyelins, diglycerides, triglycerides, cholesterol esters, phosphatidylethanolamine and lysophosphatidylethanolamines.

    All lipid metabolic markers in saliva will be reported in micromol (µM).

    Measured: Pre-training (baseline) and post-training (immediately after the training)

  7. Change in levels of other lipid metabolic markers determined in saliva samples

    Lipid metabolic marker levels (described below) will be measured in saliva samples using a collection tube (15 mL Falcon tube). Liquid chromatography (UHPLC 1290 Infinity II Series, Agilent Technologies) coupled to triple quadrupole mass spectrometry (QqQ/MS 6490 Series, Agilent Technologies) will be used as metabolomic techniques.

    Measured lipids: oxylipins, non-esterified fatty acids, hormones, and acetylcarnitines.

    All lipid metabolic markers in saliva will be reported in micromol (µM).

    Measured: Pre-training (baseline) and post-training (immediately after the training)

  8. Change in levels of polar metabolites determined in saliva samples

    Polar metabolites (described below) will be measured in saliva samples using a collection tube (15 mL Falcon tube). Gas chromatography coupled to quadrupole - time of flight mass spectrometry (GC-qTOF 7200 Series, Agilent Technologies) will be used as metabolomic techniques.

    Measured polar metabolites: organic acids, amino acids, compounds related to energy metabolism and sugars.

    All polar metabolites in saliva will be reported in micromol (µM).

    Measured: Pre-training (baseline) and post-training (immediately after the training)

  9. Change in levels of proteomic markers determined in capillary blood samples

    Proteomic marker levels will be determined using the same DBS device as in the case of the primary outcome. The proteins in blood will be digested with trypsin to obtain peptides. The peptides will be analyzed by liquid nanochromatography coupled to mass spectrometry. The identification of the proteins will be carried out using the UniProt Homo Sapiens database using the Proteome Discoverer software (ThermoFisher Scientific).

    All proteomic markers in capillary blood will be reported in arbitrary units as a relative unit of measurement.

    Measured: Pre-training (baseline) and post-training (immediately after the training)

  10. Change in levels of proteomic markers determined in saliva samples

    The proteins in saliva will be digested with trypsin to obtain peptides. The peptides will be analyzed by liquid nanochromatography coupled to mass spectrometry. The identification of the proteins will be carried out using the UniProt Homo Sapiens database using the Proteome Discoverer software (ThermoFisher Scientific).

    All proteomic markers in saliva will be reported in arbitrary units as a relative unit of measurement.

    Measured: Pre-training (baseline) and post-training (immediately after the training)

  11. Pittsburgh Sleep Quality Index

    It is a validated scale that measures the usual sleep habits during the past month. It consists of 7 areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. It contains a total of 19 items, grouped into 10 questions where each of the areas evaluated is scored between 0 and 3. The scores from the seven areas are finally added up to give an overall score. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

    Measured: Pre-training (baseline)

  12. Heart rate variations

    It will be measured, in bpm, in real time throughout training using an optical heart rate sensor (Polar Verity Sense) fitted to the left arm of each player with a textile elastic armband. The device monitors heart rate in real time. The average heart rate will be calculated with the data collected throughout the training.

    Measured: During the training

  13. Sociodemographic data: age and birth date

    Age will be recorded in years, and birth date in the format DD/MM/YYYY. It will be recorded in the case report form.

    Measured: Pre-training (baseline)

  14. Sociodemographic data: sex

    Sex will be recorded as male or female in the case report form.

    Measured: Pre-training (baseline)

  15. Lifestyle data: weekly training load

    Weekly training load will be recorded as hours/week in the case report form.

    Measured: Pre-training (baseline)

  16. Lifestyle data: playing position

    Playing position, will be recorded as base, shooting guard, small forward, power forward or center in the case report form.

    Measured: Pre-training (baseline)

  17. Clinical data: use of supplementation

    Use of supplementation will be recorded in the case report form.

    Measured: Pre-training (baseline)

  18. Clinical data: use of medication

    Use of medication will be recorded in the case report form.

    Measured: Pre-training (baseline)

  19. Clinical data: previous muscle injuries

    Previous muscle injuries will be recorded in the case report form.

    Measured: Pre-training (baseline)

  20. Physiological data

    Physiological data, including presence of current menstruation in women, will be recorded in the case report form.

    Measured: Pre-training (baseline)

  21. Anthropometric data: weight

    Weight will be measured in kg with a portable digital scale (Beuer b180) and recorded in the case report form.

    Measured: Pre-training (baseline)

  22. Anthropometric data: height

    Height will be measured in cm with a portable stadiometer and recorded in the case report form.

    Measured: Pre-training (baseline)

  23. Anthropometric data: body mass index

    Body mass index will be recorded in kg/m² in the case report form.

    Measured: Pre-training (baseline)

  24. Anthropometric data: fat mass percentage

    Fat mass percentage (%) will be measured with a portable digital scale (Beuer b180) and recorded in the case report form.

    Measured: Pre-training (baseline)

  25. Anthropometric data: muscle mass percentage

    Muscle mass percentage (%) will be measured with a portable digital scale (Beuer b180) and recorded in the case report form.

    Measured: Pre-training (baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2024
  2. Study start4 Oct 2024
  3. Primary completion1 Apr 2025
  4. Study completion1 Apr 2025

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single-group pretest-posttest design (quasi- experimental)
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06365320
Sponsor's protocol ID
PROTEOMET
Acronym
PROTEOMET
Status last verified
Apr 2025
First submitted
25 Mar 2024
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Single basketball training in people with Lactate and Sports Performance, run by Fundació Eurecat at 2 sites in Spain.

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 2 inclusion and 8 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 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

Correlation between blood lactate levels and the subjective sensation of perceived effort (time frame: Pre-training (baseline) and post-training (immediately after the training)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Apr 2025.

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