NCT05703100

Brief Summary

The goal of this clinical trial is to test whether changes in lactate kinetics during exercise (due to glycogen depletion or hyperthermia) alter the pattern of fat oxidation during a maximal incremental cycle ergometer test in healthy young active people. The main questions it aims to answer are:

  • Will a rightward shift in lactate kinetics, induced by a previous glycogen depletion, produce a rightward shift in fat oxidation?
  • Will a leftward shift in lactate kinetics due to an increase in ambient temperature produce a leftward shift in fat oxidation? Participants will perform three maximal incremental tests in three different conditions:
  • one in the control condition;
  • one with glycogen depletion;
  • and one with ambient heat (the latter two in randomized, counterbalanced order).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

January 11, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

January 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

January 11, 2023

Last Update Submit

September 12, 2023

Conditions

Keywords

lactate kineticsexerciseenergy metabolismhyperthermiaglycogen depletion

Outcome Measures

Primary Outcomes (2)

  • Blood lactate concentration

    Lactate concentration, expressed in mMol/L (Millimoles Per Liter), measured in capillary blood using a lactate analyser. Lactate concentration is measured in the capillary blood extracted from the fingertip, during the tests performed in the different situations (control, glycogen depletion and hyperthermia)

    Through study completion, an average of 5 months

  • Fat oxidation

    Fat oxidation, expressed in g/min, is indirectly measured through the analysis of the gas composition of breathing (O2 and CO2), using a gas analyser. Fat oxidation is measured during the tests performed in the different situations (control, glycogen depletion and hyperthermia)

    Through study completion, an average of 5 months

Secondary Outcomes (2)

  • Heart Rate

    Through study completion, an average of 5 months

  • Power output

    Through study completion, an average of 5 months

Study Arms (3)

Control

ACTIVE COMPARATOR

Maximal test on a cycle ergometer

Other: Incremental exercise test

Hyperthermia

EXPERIMENTAL

Maximal test on a cycle ergometer at 35º-38º C room temperature

Other: Incremental exercise test under hyperthermia

Glycogen depletion

EXPERIMENTAL

Maximal test on a cycle ergometer after a glycogen depletion protocol

Other: Incremental exercise test under glycogen depletion

Interventions

Maximal incremental exercise test on a cycle ergometer (5 min warm-up at 30W, and subsequent steps of 3 min with power increases of 30W)

Also known as: Maximal incremental ergometry
Control

Maximal incremental exercise test on a cycle ergometer (5 min warm-up at 30W, and subsequent steps of 3 min with power increases of 30W) performed at a room temperature of 35-38ºC (degrees Celsius).

Also known as: Maximal incremental ergometry with hyperthermia
Hyperthermia

Maximal incremental exercise test on a cycle ergometer (5 min warm-up at 30W, and subsequent steps of 3 min with power increases of 30W) under glycogen depletion by performing an exercise protocol to deplete glycogen stores plus a low-carbohydrate diet 24 h before incremental testing

Also known as: Maximal incremental ergometry with glycogen depletion
Glycogen depletion

Eligibility Criteria

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

You may qualify if:

  • Perform endurance training with a volume of between 3 and 12h/week
  • In women, having regular menstrual cycles (25-35 days length)
  • In women, being able to perform the test without menstrual discomfort or pain and without having taken anti-inflammatory or analgesic drugs

You may not qualify if:

  • Suffering from any previous disease, disorder or ailment that could affect the results of the study variables
  • Smoking
  • In women, using any type of hormonal contraceptive
  • In women, having heavy menstrual bleeding, detected with the menstrual bleeding questionnaire proposed by Wyatt et al. (2001)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Madrid, 28040, Spain

Location

Related Publications (2)

  • Wyatt KM, Dimmock PW, Walker TJ, O'Brien PM. Determination of total menstrual blood loss. Fertil Steril. 2001 Jul;76(1):125-31. doi: 10.1016/s0015-0282(01)01847-7.

    PMID: 11438330BACKGROUND
  • Benitez-Munoz JA, Guisado-Cuadrado I, Rojo-Tirado M, Alcocer-Ayuga M, Romero-Parra N, Peinado AB, Cupeiro R. Females have better metabolic flexibility in different metabolically challenging stimuli. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-12. doi: 10.1139/apnm-2024-0217. Epub 2024 Oct 22.

MeSH Terms

Conditions

Motor ActivityHyperthermia

Interventions

Diathermy

Condition Hierarchy (Ancestors)

BehaviorBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Officials

  • Rocío Cupeiro, PhD

    Universidad Politecnica de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No Masking is possible since participants and investigators know which type of test (control, hyperthermia and glycogen depletion) is being performed.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Activity and Sports PhD (Associate Professor)

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 27, 2023

Study Start

January 28, 2023

Primary Completion

May 11, 2023

Study Completion

May 11, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations