Healthy Adult ParticipantsNCT07504718
The Effect of Cold Exposure on Physiological Markers
A study testing Cold water immerssion in people with Healthy Adult Participants, run by Lithuanian Sports University at 1 site in Lithuania.
Trial summary
The goal of this observational study is to examine how different physiological markers change over a two-day period after long-duration whole-body cold-water immersion in healthy young men and women. Read more about this study
- Who is it for?
- Ages 18 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Cold water immerssion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteLithuania
- Study dates
- 13 May 2013to 6 May 2018
- 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 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults;
- Age between 18 and 36 years;
- No excessive sporting activities;
- No participation in any temperature-manipulation program or exposure to extreme temperatures within the past 12 weeks.
Who cannot join
- Smokers;
- Use of medication that could affect natural thermoregulation;
- Body mass index greater than 30 kg/m²;
- History of asthma, neurological conditions, cardiovascular disease, or any condition that could be adversely affected by cold exposure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cold Water Immersion on Physiological Markers
The goal of this observational study is to examine how different physiological markers change over a two-day period after long-duration whole-body cold-water immersion in healthy young men and women. Specifically, the study aims to address the following questions:
- How do kynurenine pathway metabolites change after cold exposure?
- How do stress markers change after cold exposure?
- How do cytokine levels change after cold exposure?
- How do white blood cells count and distribution change after cold exposure?
- Conditions
- Healthy Adult Participants
- Being tested
- Cold water immerssion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold water immerssionOther
This intervention consisted of intermittent whole-body immersion in 14 °C water. After 20 min of immersion, the subject exited from the bath and rested for 10 min by sitting in the room environment, and then the same procedure was repeated. The cold stress continued until 170 min in total (120 min maximum total immersion time).
| Study group | Role | What they receive |
|---|---|---|
| Cold water immerssion | Experimental | Participants in this arm underwent a long-duration intermittent whole-body cold water immersion protocol. The intervention lasted for 170 minutes in total, using water maintained at a constant temperature of 14°C. Receives: Other: Cold water immerssion |
| Control | No intervention | Participants in this arm remained at an ambient temperature of 24 °C without whole-body cold water immersion protocol. The control intervention lasted for 170 minutes in total. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma metabolites of the kynurenine pathway (μm)
An ultra-performance liquid chromatography-tandem mass spectrometry system (UPLC-MS/MS) was used to measure venous plasma levels of tryptophan, kynurenine, kynurenic acid, 3-hydroxy-kynurenine, quinolinic acid, nicotinamide and picolinic acid (in μm). The UPLC-MS/MS system uses a Xevo TQ-XS triple quadrupole mass spectrometer (Waters) with a Z-spray electrospray interface, and the system operates in electrospray positive multiple reaction monitoring mode.
Measured: 2 days
Body temperature (°C)
Rectal temperature (in °C) was measured using a thermocouple (Rectal Probe, Ellab, Denmark) inserted to a depth of 12 cm past the anal sphincter, skin temperature (in °C) was measured with thermistors (Skin/Surface Probe, DM852, Ellab).
Measured: 1 day
Cold strain index
A cold strain index (CSI) was used to indicate cold strain. CSI = 6.67 x (Tre t - Tre 0) x (35 - Tre 0)^-1 + 3.33 x (Tsk t - Tsk 0) x (20 - Tsk 0)^-1, where rectal temperature (Tre) 0 and skin temperature (Tsk) 0 are initial measurements and Tre t and Tsk t are simultaneous measurements taken at the end of the cold exposure.
Measured: 1 day
Free cortisol concentration (µg/dl)
The saliva samples was collected to measure free cortisol level (in µg/dl) using an ELISA kit and a Spark multimode microplate reader (Tecan, Austria).
Measured: 2 days
Cytokines concentrations (pg/ml)
The venous tumor necrosis factor alpha and interleukin-6 (in pg/ml) were measured using an ELISA kits and a Gemini Analyzer (Stratec Biomedical GmbH, Birkenfeld, Germany)
Measured: 2 days
Total cortisol concentration (nmol/l)
The venous total cortisol consentration (in nmol/l) was measured using an ELISA kit and an automated enzyme immunoassay analyzer (AIA-2000; Tosoh Corp., Tokyo, Japan).
Measured: 2 days
Catecholamines concentration (ng/ml)
The venous adrenaline and noradrenaline concentrations (in ng/ ml) were measured using an Elisa kit and a Spark multimode microplate reader (Tecan, Austria).
Measured: 2 days
Complete blood count (10^9/L)
Complete blood count with 5 different white blood count components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in 10^9/L) was performed using an automated hematology analyzer (XE-5000, Sysmex Corp, Kobe, Japan).
Measured: 2 days
Glucose (mmol/l)
The glucose concentration (in mmol/l) was measured using a Cardiocheck PA analyzer (Polymer Technology Systems Inc, Indianapolis, IN, USA).
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start13 May 2013
- Primary completion6 May 2018
- Study completion6 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian Sports University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504718
- Sponsor's protocol ID
- LithuanianSportsU-29
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Water Immersion on Physiological Markers
- ClinicalTrials.gov ID
- NCT07504718
- Acronym / sponsor ID
- LithuanianSportsU-29
- Conditions
- Healthy Adult Participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Lithuanian Sports UniversityUniversity, hospital or other
- Study start
- 13 May 2013 (actual)
- Primary completion
- 6 May 2018 (actual)
- Study completion
- 6 May 2018 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to examine how different physiological markers change over a two-day period after long-duration whole-body cold-water immersion in healthy young men and women. Specifically, the study aims to address the following questions:
- How do kynurenine pathway metabolites change after cold exposure?
- How do stress markers change after cold exposure?
- How do cytokine levels change after cold exposure?
- How do white blood cells count and distribution change after cold exposure?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold water immerssion | Experimental | Other: Cold water immerssionParticipants in this arm underwent a long-duration intermittent whole-body cold water immersion protocol. The intervention lasted for 170 minutes in total, using water maintained at a constant temperature of 14°C. |
| Control | No intervention | –Participants in this arm remained at an ambient temperature of 24 °C without whole-body cold water immersion protocol. The control intervention lasted for 170 minutes in total. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults;
- Age between 18 and 36 years;
- No excessive sporting activities;
- No participation in any temperature-manipulation program or exposure to extreme temperatures within the past 12 weeks.
Key exclusion criteria (4 listed)
- Smokers;
- Use of medication that could affect natural thermoregulation;
- Body mass index greater than 30 kg/m²;
- History of asthma, neurological conditions, cardiovascular disease, or any condition that could be adversely affected by cold exposure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold water immerssionThis intervention consisted of intermittent whole-body immersion in 14 °C water. After 20 min of immersion, the subject exited from the bath and rested for 10 min by sitting in the room environment, and then the same procedure was repeated. The cold stress continued until 170 min in total (120 min maximum total immersion time). | Other | Cold water immerssion |
Primary outcome
Change in plasma metabolites of the kynurenine pathway (μm)
Time frame: 2 days
An ultra-performance liquid chromatography-tandem mass spectrometry system (UPLC-MS/MS) was used to measure venous plasma levels of tryptophan, kynurenine, kynurenic acid, 3-hydroxy-kynurenine, quinolinic acid, nicotinamide and picolinic acid (in μm). The UPLC-MS/MS system uses a Xevo TQ-XS triple quadrupole mass spectrometer (Waters) with a Z-spray electrospray interface, and the system operates in electrospray positive multiple reaction monitoring mode.
Body temperature (°C)
Time frame: 1 day
Rectal temperature (in °C) was measured using a thermocouple (Rectal Probe, Ellab, Denmark) inserted to a depth of 12 cm past the anal sphincter, skin temperature (in °C) was measured with thermistors (Skin/Surface Probe, DM852, Ellab).
Cold strain index
Time frame: 1 day
A cold strain index (CSI) was used to indicate cold strain. CSI = 6.67 x (Tre t - Tre 0) x (35 - Tre 0)^-1 + 3.33 x (Tsk t - Tsk 0) x (20 - Tsk 0)^-1, where rectal temperature (Tre) 0 and skin temperature (Tsk) 0 are initial measurements and Tre t and Tsk t are simultaneous measurements taken at the end of the cold exposure.
Free cortisol concentration (µg/dl)
Time frame: 2 days
The saliva samples was collected to measure free cortisol level (in µg/dl) using an ELISA kit and a Spark multimode microplate reader (Tecan, Austria).
Cytokines concentrations (pg/ml)
Time frame: 2 days
The venous tumor necrosis factor alpha and interleukin-6 (in pg/ml) were measured using an ELISA kits and a Gemini Analyzer (Stratec Biomedical GmbH, Birkenfeld, Germany)
Total cortisol concentration (nmol/l)
Time frame: 2 days
The venous total cortisol consentration (in nmol/l) was measured using an ELISA kit and an automated enzyme immunoassay analyzer (AIA-2000; Tosoh Corp., Tokyo, Japan).
Catecholamines concentration (ng/ml)
Time frame: 2 days
The venous adrenaline and noradrenaline concentrations (in ng/ ml) were measured using an Elisa kit and a Spark multimode microplate reader (Tecan, Austria).
Complete blood count (10^9/L)
Time frame: 2 days
Complete blood count with 5 different white blood count components (absolute neutrophils, lymphocytes, monocytes, eosinophils, basophils) analysis (in 10^9/L) was performed using an automated hematology analyzer (XE-5000, Sysmex Corp, Kobe, Japan).
Glucose (mmol/l)
Time frame: 2 days
The glucose concentration (in mmol/l) was measured using a Cardiocheck PA analyzer (Polymer Technology Systems Inc, Indianapolis, IN, USA).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold water immerssion in people with Healthy Adult Participants, run by Lithuanian Sports University at 1 site in Lithuania.
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 4 inclusion and 4 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. 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?
Change in plasma metabolites of the kynurenine pathway (μm) (time frame: 2 days). The study lists 9 primary outcomes in all. 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 7 Apr 2026.