Recruiting NCT06346639
Effect of a 16-day Hot and Cold Acclimation on Adaptive Responses and Health-related Indicators
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 16-day hot and cold acclimation.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lithuania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Time Course of Adaptive Responses in Humans During a 16-day Hot and Cold Acclimation Program, and Its Effect on Health-related Indicators
Overview
There are no previous studies of the effects of a combination of whole-body immersions in hot and cold baths on adaptive responses and health-related markers. Thus, the primary aim of this project is to determine whether interventions consisting of whole body immersion in hot and cold baths over 16 days develop heat and/or cold adaptation by remodeling thermoregulatory, metabolic, cardiovascular and physiological responses, and the secondary aim is to determine if current cold-hot acclimation has any effects on physical and mental health-related markers.
Interventions
- Other 16-day hot and cold acclimation
Acclimation program will consist of 8 brief cold water immersions (CWI; 14°C 5 min) and 8 hot water immersions (HWI; 45°C 5 min). Heat and cold sessions will be performed on separate days (i.e., 1st day hot exposure, 2nd day cold exposure, 3rd day hot exposure, etc.).
Primary outcome measures
- Change in body mass and body composition (kg) [Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
- Change in skinfold thickness (mm) [Time frame: Before acclimation (1st day), 2 days and 2 weeks after the end of acclimation (44 th and 51st day)]
- Change in body mass index (kg/m^2) [Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
- Change in body surface area (m^2) [Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
- Change in substrate oxidation [Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
- Change in substrate oxidation (g/day) [Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
- Change in ventilation (l/min) [Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
- Change in breathing frequency (t/min) [Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
- Change in resting energy expenditure (kcal/day) [Time frame: Before acclimation (1st day), during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days), and 2 weeks after the end of acclimation (51st day)]
- Change in metabolic heat production (W) [Time frame: during baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days)]
Secondary outcome measures (4)
- Height (m) [Time frame: Before acclimation (1st day)]
- Change in physical activity (in h) [Time frame: 3 days before first assessment, during 16-day acclimation period and during 2 week post-acclimation period.]
- Change in sleep (in h) [Time frame: 3 days before first assessment, during 16-day acclimation period and during 2 week post-acclimation period.]
- Change in oxygen saturation (percent) [Time frame: During baseline provocative tests (8th and 15th day), during acclimation (from 22 to 37th days), during repeated provocative tests (41st and 42nd days)]
Eligibility criteria
Inclusion criteria
- young, healthy, non-obese males and females;
- nonsmoker;
- no needle phobia;
- not taking medication and/or dietary supplements that may affect experimental variables.
Exclusion criteria
- neurological, cardiovascular, metabolic, and/or inflammatory diseases, or conditions that could be worsened by exposure to acute thermal stimuli and that could affect experimental variables;
- involvement in temperature manipulation program for ≥ 3 months;
- attendance at any excessive formal physical exercise or sports program.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Lithuania · 1 center
- Lithuanian Sports University — Kaunas
Identifiers
NCT: NCT06346639 · LithuananianSportsU-17