Clinical trial NCT06667479: Cold Water Exposure and Immune Function Study
Official title: Effects of a 4 Week Cold Tub Vs Cold Shower Immersion Intervention on Immune Function, Sleep Quality, Mental Health and Well-being, Gut Health, and Muscular Strength in Healthy, Physically Active Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cold Water Immersion
Immune Function
Muscular Strength
Mental Health
Keywords: Cold Water Immersion
Cold Tub
Cold Shower
Immune Function
Mental Health
Muscular Strength
Healthy Adults
Inflammation
Gut Health
Lead sponsor: University of Northern Colorado
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel, randomized design, matched for biological age
Primary purpose: OTHER

Brief summary: The purpose of this clinical trial is to explore the effects of a 4 week cold-water immersion (CWI) intervention on measures of immune function, sleep quality, mental health and well-being, and muscular strength. The main questions it aims to answer are:

* Does a 4 week CWI intervention improve measures of immune function, sleep quality, mental health and well-being, and muscular strength?
* Are there any differences in these measures when comparing cold tubs versus cold showers?

Researchers will compare chronic use of cold tubs to cold showers to see if cold water immersion may improve overall immune health and well-being.

Participants will:

* Undergo 4 weeks of Cold Tub or Cold Shower interventions at a frequency of 3 times a week for 4 minutes, if placed in the CWI intervention groups
* Undergo testing measures at the two pre- and post- intervention time points, if placed in the healthy control group or the CWI intervention groups


Eligibility criteria: Inclusion Criteria:

* Males and Females
* Aged 18-45

Exclusion Criteria:

* Currently practices CWI for \[\&gt;3 times in the last month\]
* Pregnant or planning to become pregnant
* Chronic use of anti-inflammatory medication
* Prior history of chronic disease conditions:
* Cardiovascular Disease
* Diabetes
* Cancer
* Raynaud\&#39;s Disease
* Severe and untreated anxiety or depression

Primary outcomes:
measure: C-Reactive Protein
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours.
measure: Lipopolysaccharide Binding Protein (LBP)
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours.
measure: Zonulin (Haptoglobin-2 Precursor)
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours.
measure: Interleukin-6 (IL-6)
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 3 hours.
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Visit 1A (Week 1) and 2A (Week 4): 10 minutes each
measure: Depression Anxiety and Stress Scales (DASS-21)
timeFrame: Visit 1A (Week 1) and 2A (Week 4): 10 minutes each
measure: Handgrip Dynamometry
timeFrame: Visit 1B (Week 1) and Visit 2B (Week 4): 10 minutes each
measure: Gastrointestinal Symptoms Questionairre (GSQ)
timeFrame: Completed During Visit 1A and 2A (10 minutes)
Other outcomes:
measure: Lean Body Mass
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4): 20 minutes each
measure: Body Fat Percentage
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4): 20 minutes each
measure: Immune Status Questionnaire (ISQ)
timeFrame: Visit 1A (Week 1): 5 minutes
measure: CWI Perceptions Qualitative Assessment
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4): 10 minutes each
measure: Visual Analogue Scale (VAS) of Discomfort
timeFrame: Each CWI Intervention Session: 10 seconds
measure: Natural Killer Cell Count
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 8 hours.
measure: Natural Killer T Cell Count
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 8 hours.
measure: Natural Killer Cell Cytotoxicity Assay
timeFrame: Visit 1A (Week 1) and Visit 2A (Week 4): 15 minutes for blood draw. The assay itself takes 8 hours.
Locations:
city: Greeley
country: United States
facility: University of Northern Colorado - Gunter Hall
state: Colorado
Study officials:
References: