NCT06104150

Brief Summary

The goals of this clinical trial are:

  • In phase I, trained participants will perform one maximal incremental test and one intervallic submaximal test with a final active recovery.
  • Phase II, levels of the MCT1 protein in the erythrocyte membrane will be quantified from trained and sedentary participants.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Progress84%
Feb 2020Jul 2027

Study Start

First participant enrolled

February 3, 2020

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

7.4 years

First QC Date

October 19, 2023

Last Update Submit

September 5, 2025

Conditions

Keywords

lactate kineticsMCT1erythrocyte lactateT1470A polymorphismexercise

Outcome Measures

Primary Outcomes (2)

  • Plasma-Erythrocyte lactate difference

    Difference between lactate concentration inside the erythrocytes and lactate concentration in plasma, expressed in mMol/L (Millimoles Per Liter), from venous blood extracted during the intervallic test from the antecubital vein.

    Through Phase I of the project, only in the intervallic submaximal test. Average of 3 years

  • Level of Monocarboxylate Transporter 1 in erythrocytes membrane

    Protein abundance of the monocarboxylate transporter 1 in erythrocyte membranes. It is measured using flow cytometry, from venous blood extracted from the forearm in rest state.

    Through study completion, average of 5 years, an average of 2 months per participant

Secondary Outcomes (4)

  • Erythrocyte lactate concentration

    Through Phase I of the project, only in the intervallic submaximal test. Average of 3 years

  • Plasma lactate concentration

    Through Phase I of the project, only in the intervallic submaximal test. Average of 3 years

  • Blood lactate concentration

    Through Phase I of the project, only in the intervallic submaximal test. Average of 3 years

  • Blood pH

    Through Phase I of the project, only in the intervallic submaximal test. Average of 3 years

Other Outcomes (2)

  • Genotype for the rs1049434 polymorphism of the SLC16A1 (MCT1) gene

    Through sample recruitment, average of 5 years, an average of 1 month per participant

  • Physical Activity level

    Through sample recruitment, average of 5 years, an average of 1 month per participant

Study Arms (1)

Intervallic submaximal test

EXPERIMENTAL

Intervallic exercise test

Other: Intervallic submaximal exercise test

Interventions

Intervallic submáximal exercise test on a cycle ergometer: 5 min warm-up at 80% of First Lactate Threshold (LT1), and subsequent sets of 1.5 min at 20% above the Second Lactate Threshold (LT2) alternated with recoveries of 5 min at 80% of LT1, ending with a 20 min recovery at 80% of LT1.

Also known as: Interval exercise training
Intervallic submaximal test

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18 and 25 kg/m2
  • Not smoker
  • In the case of trained participants: training at least 5 hours/week, of which at least 3 must be aerobic/anaerobic endurance training. Presentation of a medical certificate attesting to their medical fitness (capability) to perform intense physical exercise.
  • In the case of sedentary participants, less than 1 day of training per week or less than 2 hours of structured exercise per week.

You may not qualify if:

  • Presenting any pathology that could impede the correct performance of the tests, or could influence the main study variables.
  • In the case of the female sample, having irregular menstrual cycles, oligomenorrhea or amenorrhea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laboratorio de Pediatría. School of Medicine. Univesidad de Cantabria

Santander, Cantabria, 39011, Spain

RECRUITING

Laboratorio de Fisiología del Esfuerzo. Facultad de Ciencias de la Actividad Física y del Deporte (INEF). Universidad Politécnica de Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (1)

  • Benitez-Munoz JA, Rojo-Tirado MA, Benito Peinado PJ, Murias JM, Gonzalez-Lamuno D, Cupeiro R. Greater Relative First and Second Lactate Thresholds in Females Compared With Males: Consideration for Exercise Prescription. Int J Sports Physiol Perform. 2024 Oct 28;20(1):30-36. doi: 10.1123/ijspp.2024-0079. Print 2025 Jan 1.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rocío Cupeiro, PhD

    Universidad Politecnica de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocío Cupeiro, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Activity and Sports PhD (Associate Professor)

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 27, 2023

Study Start

February 3, 2020

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations