NCT06365320

Brief 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 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

October 4, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 25, 2024

Last Update Submit

April 14, 2025

Conditions

Keywords

Physical trainingLactateDried Blood Spot MethodBasketball

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (25)

  • Change in saliva lactate levels

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

  • Change in blood lactate levels

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

  • Change in levels of lipid metabolic markers determined in capillary blood samples

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

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

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

  • Change in levels of polar metabolites determined in capillary blood samples

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

  • +20 more secondary outcomes

Study Arms (1)

Pre-test and post-test measurements

EXPERIMENTAL

Before 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.

Other: Single basketball training

Interventions

Single basketball training session with fixed intensity and duration

Pre-test and post-test measurements

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fundació Eurecat, Center for Omic Sciences

Reus, Tarragona, 43204, Spain

Location

Fundació Eurecat

Reus, Tarragona, 43204, Spain

Location

Related Links

Study Officials

  • Nuria Canela, PhD

    Fundació Eurecat, Center for Omic Sciences

    PRINCIPAL INVESTIGATOR
  • Antoni Caimari, PhD

    Fundació Eurecat, Biotechnology Area

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Given the nature of the study (pretest-posttest design), masking will not be possible.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single-group pretest-posttest design (quasi- experimental)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 15, 2024

Study Start

October 4, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations