CClinicalTrials.gg
CompletedNCT07504718Updated Apr 7, 2026

The Effect of Cold Exposure on Physiological Markers

An interventional study of Cold water immerssion in Healthy Adult Participants, sponsored by Lithuanian Sports University. Completed at 1 site in Lithuania. Open to participants aged 18 Years to 36 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.

Sponsored by Lithuanian Sports University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 12 years 10 months after the study started (first participant enrolled May 2013, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 36 Years
Sex
All
01

Study 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. 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?
02

Conditions studied

  • Healthy Adult Participants
03

In context

Lead sponsor

Lithuanian Sports University is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 36 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Cold water immerssion

    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.

    Other: Cold water immerssion

  • No intervention
    Control

    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.

Interventions

  • OtherCold water immerssion

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 days

  2. 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).

    Time frame: 1 day

  3. 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.

    Time frame: 1 day

  4. 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).

    Time frame: 2 days

  5. 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)

    Time frame: 2 days

  6. 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).

    Time frame: 2 days

  7. 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).

    Time frame: 2 days

  8. 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).

    Time frame: 2 days

  9. Glucose (mmol/l)

    The glucose concentration (in mmol/l) was measured using a Cardiocheck PA analyzer (Polymer Technology Systems Inc, Indianapolis, IN, USA).

    Time frame: 2 days

07

Study locations

1 site
  • Lithuanian Sports University
    Kaunas, LT-44221, Lithuania
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07504718
Lead sponsor
Lithuanian Sports University
Responsible party
Sponsor
First posted
Apr 1, 2026
Start date
May 13, 2013
Primary completion
May 6, 2018
Completion
May 6, 2018
Last update
Apr 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion