Clinical trial NCT06654167: Acute Effects of Cold Exposure on Cognitive Function
Official title: Acute Effects of Cold Exposure on Cognitive Function and Underlying Mechanism
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cognitive Function
Keywords: Low temperature
Randomized controlled trial
Cognitive function
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low-temperature exposure on cognitive function and the underlying mechanisms.

Detailed description: The investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (15℃) and once to the moderate temperature (22℃) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include cognitive function tests and magnetic resonance imaging. Investigators plan to collect blood and urine samples.

Eligibility criteria: Inclusion Criteria:

* Living in Shanghai during the study period;
* Body mass index \> 18.5 and ≤ 28;
* right-handed;
* receiving or having received higher education;
* with the ability to read and understand Chinese smoothly.

Exclusion Criteria:

* Smoking and alcohol abuse;
* Current drug and dietary supplements intake;
* Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
* Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
* Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
* Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
* Subjects who have a history of major surgery due to the cardiovascular, cerebrovascular, respiratory, or neurological diseases;
* Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia;
* Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
* Subjects with color vision disabilities.

Primary outcomes:
measure: Results of Stroop Tests
timeFrame: before exposure and immediately after the exposure session
Secondary outcomes:
measure: Results of simple reaction time
timeFrame: before exposure and immediately after the exposure session
measure: Activated brain regions demonstrating neural activity related to the high temperature exposure
timeFrame: 1 hour after exposure session
measure: Activated brain regions demonstrating neural connectivity related to the high temperature exposure
timeFrame: 1 hour after exposure session
measure: Activated brain regions demonstrating neural synchronization related to the high temperature exposure
timeFrame: 1 hour after exposure session
measure: Changes of skin temperature
timeFrame: Skin temperature will be examined during the 2-hour exposure session (i.e., 1:00 P.M. to 3:00 P.M. on the day of the exposure session)
Other outcomes:
measure: Differences in RNA expression levels detected in serum transcriptomics between the two exposures
timeFrame: 1 hour after the exposure session
measure: Change in brain-derived neurotrophic factor (BDNF) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in glial cell line-derived neurotrophic factor (GDNF) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in γ-aminobutyric acid (GABA) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in Interleukin-1β (IL-1β) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in Interferon-β (IFN-β) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in glutathione (GSH) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Changes of the scores of thermal sensation questionnaires
timeFrame: before exposure and immediately after the exposure session
Locations:
city: Shanghai
country: China
facility: Department of Environmental Health, School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Haidong Kan, PhD
role: STUDY_DIRECTOR
References: