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Cold Water and Decision-Making (CoVa)

G

German Institute of Human Nutrition

Status

Enrolling

Conditions

Behavior
Psychological Wellbeing
Quality of Life
Stress

Treatments

Behavioral: Cold-water immersion
Behavioral: Warm-water immersion (Control)

Study type

Interventional

Funder types

Other

Identifiers

NCT06908447
01GP2210C (Other Grant/Funding Number)
CoVa

Details and patient eligibility

About

The behavioral within-subject cross-over design study "CoVa" aims to investigate the effect of a short-term full-body cold-water immersion vs. warm-water immersion control on value-based choice, psychological well-being, and peripheral physiology.

Full description

This randomized within-subject cross-over design behavioral study in cognitive neuroscience will employ an acute peripheral physiological intervention, i.e., a 10-minute full-body cold-water (10-16°C) immersion vs. a control condition (10 min @ 30- 36°C water) on two visits separated by approx. 30 days.

Forty eligible female and male participants will be subject to a head-out full-body cold-water immersion or a warm-water condition (control) on two visits. Participants will perform resting-state and task-based non-invasive electrophysiological recordings of the heart, pulse, respiration, skin conductance, and pupil, will undergo thermographic imaging, pre- and post-immersion blood sampling (4 time points), engage in two computer-based decision-making tasks (reinforcement learning task, risk decision-making task), a brief food choice task, and receive a battery of psychometric questionnaires. The visits are separated by approximately 30 days and do not differ in their timeline except for the primary intervention, i.e., cold vs warm-water immersion, and the medical screening on visit 1.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18-40 years of age
  • Consent to participate
  • Fluency in German
  • Physically and mentally healthy
  • BMI 18-30 kg/m2
  • Normal day-night rhythm

Exclusion criteria

  • Raynaud syndrome

  • Cold urticaria

  • High resting heart rate (>160 beats per minute)

  • Acute infection

  • Diagnosed current or former illnesses of

    • Brain and mind
    • Heart and blood circulation
    • Gastrointestinal system
    • Endocrine system
    • Other serious past or present medical conditions
  • Wearing of medical devices (e.g., pacemaker)

  • Fear of blood, needles, or phlebotomy

  • Allergies to plasters, gels, and other medical equipment

  • Allergies to commercially available liquid meals (e.g., shakes, yfood Labs GmbH)

  • Recurrent intake of medication which affect metabolism

  • Regular nicotine consumption (e.g., vaping, cigarettes)

  • Excessive alcohol consumption (>14 servings/week)

  • Recent illegal drug consumption (within 2 weeks prior)

  • Strong mental or physical stress

  • Excessive exercise (>2 h high-intensity exercise/day)

  • Pregnancy or breastfeeding

  • Inability to wear skin-exposing swimwear, e.g., for religious reasons

  • Affinity for winter swimming, cryotherapy, breathwork (>3 times/year)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Cold-water immersion
Experimental group
Treatment:
Behavioral: Cold-water immersion
Warm-water immersion (Control)
Experimental group
Treatment:
Behavioral: Warm-water immersion (Control)

Trial contacts and locations

1

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Central trial contact

Mine Schmidt; Trust Centre of the Human Study Centre Recruitment Officer

Data sourced from clinicaltrials.gov

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