CompletedNot Applicable

The Effect of Heat Exposure on Physiological Markers

Lithuania11 participantsStarted 2021-01-11

Plain-language summary

This study is the first to examine the effects of core temperature elevation on kynurenine pathway (KP) metabolites in healthy young males. It was hypothesized that rise in core temperature due to both pasive heating and exercise will initiate a stress response, affecting the concentration of KP metabolites. Additionally, it was expected that the exercise would produce more pronounced effects due to the increased cardiovascular, mechanical, and metabolic demands associated with it. Thus, the the main purpose of the present study was to investigate and to compare the effects of two distinct heat stress modalities on KP metabolites.

Who can participate

Age range

18 Years – 36 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * healthy adults; * age between 18 - 36 years; * physically active (exercising 2-3 times per week); * non-smoking. Exclusion Criteria: * a body mass index (BMI) \> 30 kg/m2; * neurological, cardiovascular, metabolic, and/or inflammatory diseases, or conditions that could be worsened by exposure to interventions and that could affect experimental variables; * involvement in temperature manipulation program for ≥ 3 months.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in plasma metabolites of the kynurenine pathway (μm)

Timeframe: Day 1 (every 0.5 °C until rectal temperature (Trec) reached 39°C, followed by a recovery phase until Trec reached 37.5°C)

Rectal temperature (°C)

Timeframe: Day 1 (during both heating modalities until Tre reached 39°C, followed by a recovery phase until Trec reached 37.5°C)

Change in heart rate (bpm)

Timeframe: Day 1 (during both heating modalities until Tre reached 39°C, followed by a recovery phase until Trec reached 37.5°C)

Change in physiological strain index

Timeframe: Day 1 (every 0.5 °C until rectal temperature (Trec) reached 39°C, followed by a recovery phase until Trec reached 37.5°C)

Change in glucose (mmol/L)

Timeframe: Day 1 (every 0.5 °C until rectal temperature (Trec) reached 39°C, followed by a recovery phase until Trec reached 37.5°C)

Change in lactate (mmol/L)

Timeframe: Day 1 (every 0.5 °C until rectal temperature (Trec) reached 39°C, followed by a recovery phase until Trec reached 37.5°C)

Trial details

NCT IDNCT07064512

SponsorLithuanian Sports University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-12

View on ClinicalTrials.gov More Healthy Adult Male trials

Plain-language summary

Who can participate

Age range

18 Years – 36 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in plasma metabolites of the kynurenine pathway (μm)

Timeframe: Day 1 (every 0.5 °C until rectal temperature (Trec) reached 39°C, followed by a recovery phase until Trec reached 37.5°C)

Rectal temperature (°C)

Timeframe: Day 1 (during both heating modalities until Tre reached 39°C, followed by a recovery phase until Trec reached 37.5°C)

Change in heart rate (bpm)

Timeframe: Day 1 (during both heating modalities until Tre reached 39°C, followed by a recovery phase until Trec reached 37.5°C)

Change in physiological strain index

Timeframe: Day 1 (every 0.5 °C until rectal temperature (Trec) reached 39°C, followed by a recovery phase until Trec reached 37.5°C)

Change in glucose (mmol/L)

Timeframe: Day 1 (every 0.5 °C until rectal temperature (Trec) reached 39°C, followed by a recovery phase until Trec reached 37.5°C)

Change in lactate (mmol/L)

Timeframe: Day 1 (every 0.5 °C until rectal temperature (Trec) reached 39°C, followed by a recovery phase until Trec reached 37.5°C)