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临床试验/NCT06908447
NCT06908447招募中不适用

Voluntary Cold-Water Immersion Effects on Value-Based Choice

German Institute of Human Nutrition1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年8月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Risk propensity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

研究组 & 干预措施

Warm-water immersion (Control)

Experimental

干预措施: Warm-water immersion (Control) (Behavioral)

Cold-water immersion

Experimental

干预措施: Cold-water immersion (Behavioral)

结局指标

主要结局

Risk propensity

时间窗: On day 1 and after 30 days

Risk propensity, i.e., the ratio between risky and non-risky choices for each monetary value as measured in the risk decision-making task in the cold-water vs warm-water condition as described in Liu et al. (2021)

Behavioral range adaptation

时间窗: On day 1 and after 30 days

Participants will perform a computer-based reinforcement learning task described in Gueguen et al. (2024) to assess reward sensitivity in different monetary contexts. Behavioral range adaptation, which reflects value range-dependent, relative reward valuation, may be altered if reward processing itself is changed through a potent shift in the physiological state. To test whether reward processing is altered after cold vs warm water exposure, the extent to which range adaptation and reference-point centering occurs will be quantified using computational modeling methods.

Food choice

时间窗: On day 1 and after 30 days

Participants will be provided an ad libitum restaurant-like breakfast meal during which they can order various food items (e.g., bread, yogurts, cookies) in the desired amount. The ingested food type, nutritional value, and amount will be quantified to assess food preference after cold vs warm water exposure by linking the consumed food with a standardized food database (German Nutrient Database, Bundeslebensmittelschlüssel).

Heart-rate variability

时间窗: On day 1 and after 30 days

Task-based and resting-state heart-rate variability, measured with a three-point electrocardiogram (ECG)

Heart rate

时间窗: On day 1 and after 30 days

Task-based and resting-state heart rate, measured with ECG

Respiration rate

时间窗: On day 1 and after 30 days

Task-based and resting-state respiration rate, measured via a respiration belt

Relative amplitude of the respiratory signal

时间窗: On day 1 and after 30 days

Task-based and resting-state relative respiratory amplitude, measured via a respiratory belt

Event-related skin conductance responses

时间窗: On day 1 and after 30 days

Phasic electrodermal activity, measured via electrodermal activity (EDA) electrodes

Tonic skin conductance

时间窗: On day 1 and after 30 days

Tonic task-based and resting-state electrodermal activity, measured with EDA electrodes

Pupil dilation

时间窗: On day 1 and after 30 days

Task-based and resting-state pupil dilation, measured via eye-tracking

Skin temperature

时间窗: On day 1 and after 30 days

Thermographic imaging of the face, full-body, supraclavicular, and scapular area using a thermal camera pre-, during, and post-immersion

Plasma concentration of large neutral amino acids

时间窗: On day 1 and after 30 days

Large neutral amino acid (LNAA) plasma concentration will be assessed via blood sampling at 4 time points (pre-immersion to 120 min post-immersion)

Plasma concentration of catecholamines

时间窗: On day 1 and after 30 days

Catecholamines via blood sampling at 4 time points (pre-immersion to 120 min post-immersion)

Plasma concentration of cortisol

时间窗: On day 1 and after 30 days

Cortisol via blood sampling at 4 time points (pre-immersion to 120 min post-immersion)

Identification of epigenetic markers associated with acute cold exposure

时间窗: On day 1 and after 30 days

Epigenetic markers (micro-RNA) via blood sampling at 4 time points (pre-immersion to 120 min post-immersion)

Perceived control

时间窗: On day 1 and after 30 days

Psychological changes in perceived control, measured semi-continuously via self-reports throughout the experimental day. Measures range from 0% (not at all) to 100% (very much) with 100% indicating high perceived control.

Perceived freedom

时间窗: On day 1 and after 30 days

Psychological changes in perceived freedom, measured semi-continuously via self-reports throughout the experimental day. Measures range from 0% (not at all) to 100% (very much) with 100% indicating high perceived freedom.

Perceived stress

时间窗: On day 1 and after 30 days

Psychological changes in perceived stress, measured semi-continuously via self-reports throughout the experimental day. Measures range from 0% (not at all) to 100% (very much) with 100% indicating high perceived stress.

State of flow

时间窗: On day 1 and after 30 days

Psychological changes in perceived state of flow, measured semi-continuously via self-reports throughout the experimental day. Measures range from 0% (not at all) to 100% (very much) with 100% indicating a high state of flow.

Self-efficacy

时间窗: On day 1 and after 30 days

Psychological changes in self-efficacy, measured semi-continuously via self-reports throughout the experimental day. Measures range from 0% (not at all) to 100% (very much) with 100% indicating high self-efficacy.

Perceived pain

时间窗: On day 1 and after 30 days

Psychological changes in perceived pain, measured semi-continuously via self-reports throughout the experimental day. Measures range from 0% (not at all) to 100% (very much) with 100% indicating high perceived pain.

Emotions

时间窗: On day 1 and after 30 days

Psychological changes in emotions and their bodily origins, measured via self-reports pre- and post-immersion. Measures will be drawn on a virtual body using an adapted version of the Nummenmaa et al. (2014) emBODY tool with red color indicating increased perception and blue indicating decreased perception.

Positive affect and negative affect questionnaire

时间窗: On day 1 and after 30 days

Psychological changes in affect, measured semi-continuously via the Positive Affect Negative Affect (PANAS) questionnaire to be filled out pre- and post-immersion. Measures for each item range from 1 (not at all) to 5 (very much) with 5 indicating the highest feeling perceived at the moment.

次要结局

  • Trait autonomy questionnaire(On day 1 and after 30 days)
  • Emotion regulation questionnaire(On day 1 and after 30 days)
  • Causality orientation questionnaire(On day 1 and after 30 days)
  • Delay discounting questionnaire(On day 1 and after 30 days)
  • Interoceptive awareness questionnaire(On day 1 and after 30 days)
  • Generalized self-efficacy questionnaire(On day 1 and after 30 days)
  • Trait and state anxiety questionnaire(On day 1 and after 30 days)
  • Well-being questionnaire(On day 1 and after 30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Soyoung Q Park

Prof. Dr.

German Institute of Human Nutrition

研究点 (1)

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