[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cold-exposure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cold-exposure":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,73,98,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100596664","intermittent-cold-exposure-and-brown-adipose-tissue-hyperplasia-100596664",false,"NCT07048405","Intermittent Cold Exposure and Brown Adipose Tissue Hyperplasia","Investigating the Cellular Heterogeneity of Human Brown Adipose Tissue and Its (Patho)Physiological Regulation","ICEBATH","Inclusion Criteria:\n\n* Aged 18-40 years\n* Body mass index 18.5-25 kg\u002Fm2\n* Weight change of less than 5% in the past 6 months\n* No acute or chronic medical conditions\n* On no regular medications (other than contraceptives in female participants)\n* No claustrophobia\n* Alcohol intake ≤14 units\u002F week\n* Screening blood tests within acceptable limits (of no clinical significance)\n* Not currently pregnant, lactating or breastfeeding (female participants only)\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Not meeting inclusion criteria\n* Contra-indication to PET\u002FCT scan\n* Allergy to local anaesthetic",true,"ALL","18 Years","40 Years",{"count":22,"type":23},12,"ESTIMATED","INTERVENTIONAL",[26],"NA","This clinical trial explores how repeated short-term cold exposure impacts the molecular and physiological function of brown adipose tissue (BAT), a thermogenic organ associated with improved cardiometabolic health. While intermittent cold exposure has been shown to increase BAT activity and mass, as measured by fluorodeoxyglucose (18F-FDG) uptake on positron emission tomography\u002Fcomputed tomography (PET\u002FCT) scans, the molecular adaptations within BAT and other thermogenic tissues including skeletal muscle and white adipose tissue (WAT) remain poorly understood.\n\nHealthy adults aged 18 to 40 years (6 males and 6 females) will participate in a 10-day cold acclimation protocol (2 hours per day using water-perfused cooling blankets). The primary objective is to determine how cold exposure alters cellular heterogeneity and gene expression in BAT, WAT, and skeletal muscle.\n\nParticipants will undergo baseline assessments, including measurements of energy expenditure, core and skin temperature, muscle activity, and blood sampling, each performed in both warm and cold conditions. These assessments will be followed by dynamic total-body PET\u002FCT imaging during cold exposure and tissue biopsies from BAT, subcutaneous WAT, and skeletal muscle. These procedures will be repeated after the cold acclimation protocol to evaluate physiological and molecular changes. Additional outcomes include changes in energy expenditure, cold tolerance, and immune cell responses induced by cold exposure.",[29,30,31],"Brown Adipose Tissue","Cold Exposure","18F-FDG PET\u002FCT",[29,30,31],"RECRUITING","2026-06-29",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"2025-05-01",{"date":41,"type":23},"2027-07",{"name":43,"class":44},"University of Edinburgh","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":45},"100634345","phase-1-controlled-cold-exposure-combined-with-pd-1pd-l1-immunotherapy-in-solid-tumors-nivalis-100634345","NCT07538479","Controlled Cold Exposure Combined With PD-1\u002FPD-L1 Immunotherapy in Solid Tumors (NIVALIS)","NIVALIS Trial: A Single-Center, Prospective, Single-Arm, Open-Label Phase I Exploratory Study Evaluating the Safety, Feasibility, and Preliminary Antitumor Activity of Controlled Cold Exposure Combined With PD-1\u002FPD-L1 Immunotherapy in Patients With Solid Tumors","NIVALIS","Inclusion Criteria:\n\n* 1\\. Age 18-75 years, regardless of sex. 2. Histologically or cytologically confirmed malignant solid tumor. 3. Evaluated by the treating physician or multidisciplinary team (MDT) as currently planned to receive standard PD-1\u002FPD-L1 inhibitor monotherapy or a standard combination regimen containing PD-1\u002FPD-L1 inhibitors.\n\n  4\\. Applicable settings include neoadjuvant, perioperative, or conversion therapy, as well as unresectable locally advanced, recurrent, or metastatic disease planned for systemic therapy.\n\n  5\\. At least one evaluable lesion; for patients assessed by RECIST 1.1, at least one measurable lesion is required. Patients planned for surgery may also be included if adequate preoperative imaging and postoperative pathological assessment are available, even if RECIST measurability is not fully met.\n\n  6\\. ECOG performance status 0-1; selected patients with ECOG 2 may be enrolled at the investigator's discretion if considered able to tolerate the study procedures.\n\n  7\\. Expected survival ≥3 months. 8. Adequate major organ function, including hematologic, hepatic, renal, and electrolyte parameters acceptable for clinical study participation.\n\n  9\\. Cardiopulmonary function at rest adequate to tolerate the study procedures, without obvious abnormalities indicating intolerance to cold exposure.\n\n  10\\. Toxicities from prior antitumor therapy must have recovered to ≤ Grade 1, except for alopecia or clinically insignificant abnormalities judged by the investigator; for patients previously treated with PD-1\u002FPD-L1 inhibitors, at least 4 weeks must have elapsed before enrollment, and prior related adverse events must have recovered or stabilized sufficiently for re-exposure.\n\n  11\\. No clear contraindication to cold exposure, and deemed able to tolerate cold exposure combined with immunotherapy by the investigator.\n\n  12\\. Negative pregnancy test for women of childbearing potential; participants of reproductive potential must agree to use effective contraception during the study and for at least 3 months after the last dose.\n\n  13\\. Able to understand the study objectives, procedures, and potential risks, and willing to provide written informed consent.\n\n  14\\. For participants planned for neoadjuvant, perioperative, or conversion therapy, the investigator must confirm that study procedures will not delay planned surgery or other critical treatments.\n\nExclusion Criteria:\n\n* 1\\. Participation in another interventional clinical study or receipt of another investigational treatment within 4 weeks before study treatment initiation.\n\n  2\\. Uncontrolled active infection, including but not limited to severe bacterial, viral, or fungal infection, or active tuberculosis.\n\n  3\\. HIV infection; chronic HBV or HCV infection with uncontrolled viral replication or unacceptable liver function.\n\n  4\\. Known severe hypersensitivity to the intended PD-1\u002FPD-L1 inhibitor or its excipients.\n\n  5\\. Active autoimmune disease or a requirement for long-term moderate- to high-dose immunosuppressive therapy; physiological replacement-dose steroids may be allowed at the investigator's discretion.\n\n  6\\. Prior severe or life-threatening immune-related adverse events during PD-1\u002FPD-L1 inhibitor therapy that have not resolved or are considered high-risk for re-exposure.\n\n  7\\. Significant cardiovascular disease, including but not limited to unstable angina, severe arrhythmia, NYHA class III-IV heart failure, LVEF \\\u003C50%, or myocardial infarction, stroke, or severe thrombotic events within 6 months.\n\n  8\\. Severe chronic respiratory disease, especially conditions likely to worsen under cold stimulation, such as severe COPD or severe asthma.\n\n  9\\. Clear contraindications to cold exposure, including prior severe cold-related injury, cold urticaria, cryoglobulinemia, active Raynaud's syndrome, or other diseases judged by the investigator to preclude tolerance to a cold environment.\n\n  10\\. Uncontrolled symptomatic central nervous system metastases. 11. Severe psychiatric illness, cognitive impairment, substance abuse, or alcohol dependence that would interfere with compliance.\n\n  12\\. Pregnancy or breastfeeding. 13. Uncontrolled diabetes, severe malnutrition, marked frailty, or any other condition judged to make the participant unable to tolerate cold exposure or study procedures.\n\n  14\\. Any situation in which study participation may significantly delay standard therapy, planned surgery, or other critical treatment timing.","75 Years",{"count":56,"type":23},24,[58],"PHASE1","This is a single-center, prospective, single-arm, open-label phase I exploratory study that plans to enroll 24 participants with solid malignancies. All participants will receive controlled cold exposure in addition to standard PD-1\u002FPD-L1 inhibitor monotherapy or PD-1\u002FPD-L1 inhibitor-based standard combination therapy. A 2-day cold acclimation phase will precede formal intervention, consisting of approximately 20°C exposure for 8 hours on Day -2 and approximately 18°C exposure for 10 hours on Day -1. The first combination cycle begins on Day 1 concurrently with PD-1\u002FPD-L1-based treatment, with exposure to an 18°C temperature-controlled hospital room for 12 hours per day for 7 consecutive days. If tolerated, cold exposure may be repeated in subsequent PD-1\u002FPD-L1 treatment cycles. The primary objective is to evaluate safety, tolerability, and feasibility. Secondary objectives are to explore preliminary antitumor activity and the effects on brown adipose tissue activation, peripheral immune profiling, circulating cytokines, metabolomics, gut microbiota, patient-reported outcomes, and tumor immune\u002Fmetabolic biomarkers when paired tumor tissue is available.",[61,62,30,63],"Solid Tumors","Solid Malignancies","Immunotherapy","2026-05-24",{"date":66,"type":37},"2026-05-28",{"date":68,"type":37},"2026-04-20",{"date":70,"type":23},"2029-06-30",{"name":72,"class":44},"West China Hospital",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":80,"targetDuration":4,"studyType":24,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100502429","omega-3-fatty-acids-as-regulators-of-brown-adipose-tissue-during-cold-exposure-100502429","NCT05822141","Omega-3 Fatty Acids as Regulators of Brown Adipose Tissue During Cold Exposure","Omega-3 Fatty Acid Modulation of Brown Adipose Tissue for Arctic Resilience","Inclusion Criteria:\n\n* Male and female, between the ages of 18 to 40 years.\n* Body Mass Index (BMI) of 18.5 to 24.9 kg\u002Fm2\n* Considered \"moderately to highly active\" by the International Physical Activity Questionnaire (IPAQ) and the Physical Activity Readiness Questionnaire (PAR-Q+)\n\nExclusion Criteria:\n\n* History of smoking or recreational smoking, hyperlipidemia, hypertension\u002Fcardiovascular disease, diabetes, renal disease, neurological disease, metabolic disease, and bleeding disorders or delayed clotting time.\n* Taking SSRI's (antidepressants and anxiety medication), ADD\u002FADHD medication, and chronically consume pain medication (Aleve, Tylenol, CBD, etc).\n* Have or have had chronic disorders of the rectum (e.g., cancer, surgery, active hemorrhoids, etc.) or who currently have related acute conditions (diarrhea, constipation, etc.).\n* Have or have had a diagnosis of disorders related to immune suppression and\u002For autoimmune disease.\n* Are pregnant or planning on being pregnant.\n* Resting blood pressure of \\> 130mmHg systolic or 90 mmHg diastolic.\n* Resting Pulse rate of \\> 100 bpm.\n* History of regularly consuming fish oil supplements and\u002For regularly eating more than one fish meal per week.\n* Consuming more than one fish meal per week during the study.",{"count":81,"type":23},30,[26],"This clinical trial will assess the whether fish oil supplementation can modulate brown fat activation, shivering, thermal comfort and skin blood flow during cold exposure.",[30],[86,87,88],"Brown fat","Fish oil","Cold","2026-05-21",{"date":91,"type":37},"2026-05-26",{"date":93,"type":37},"2023-06-12",{"date":95,"type":23},"2026-12",{"name":97,"class":44},"Indiana University",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":24,"phases":107,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":45},"100630593","energy-dense-fueling-for-cold-weather-operations-100630593","NCT07489690","Energy Dense Fueling for Cold-Weather Operations","Inclusion Criteria: • Men and women aged 18 - 39 years (17 if active Military)\n\n* Physically active (exercise minimum 2 days per week)\n* Have supervisor approval (permanent party military and civilians at NSSC)\n* Willing to refrain from alcohol, nicotine products and dietary supplement use while on study diets\n* Females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or using oral\u002Fhormonal contraceptive which contains low-dose estrogen\u002Fprogesterone to maintain continuous levels throughout the 28-day cycle (i.e., no placebos)\n* Only consume caffeine products while on study diets if provided by study staff\n* Body mass index (BMI) between 18.5-30 kg\u002Fm2\n* In good health as determined by OMSO (Office of Medical Support and Oversight)\n\nExclusion Criteria:\n\n* Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney disease, diabetes, cardiovascular disease, hypertension etc.) that is unsuitable for the study determined by OMSO\n* Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that affects macronutrient utilization and\u002For the ability to participate in strenuous exercise\n* Allergies or intolerance to foods (including but not limited to lactose intolerance\u002Fmilk allergy), vegetarian practices\n* Present condition of alcoholism, anabolic steroids (testosterone, enanthate, undecanoate, etc), or other substance abuse issues\n* Unwilling to stop use of nutritional\u002Fsports supplements (creatine, multivitamins, whey etc.) while enrolled in the study\n* Sensitivity to medical adhesives resulting in significant skin irritation\n* Acute or chronic musculoskeletal injury that compromises the ability to run and ruck march\n* History of disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery\n* Difficulty swallowing large pills or unwilling to insert rectal temperature sensor\n* Raynaud's syndrome.\n* History of cold injuries of any severity (e.g., frostbite, trench foot, chilblains) that puts the volunteers at increased risk for an adverse effect\n* Cold-induced bronchospasms\u002Fasthma\n* Blood donation within 8 weeks of the study\n* Unwillingness or inability to adhere to study exercise restrictions\n* Scheduled MRI within 2 weeks after completing test in cold","39 Years",{"count":106,"type":23},8,[26],"High daily energy expenditures without compensatory increases in energy intakes results in severe energy deficits during cold-weather military operations. Observational and experimental data from our laboratory suggests that consuming higher-fat, energy dense products can increase energy intake and attenuate energy deficits, however, laboratory analysis is needed to understand the impact of macronutrient manipulation on substrate oxidation and aerobic performance. This proof of concept, randomized crossover study will examine the effects of consuming an isocaloric bar (approximately 350 kcal) that is higher in carbohydrate (CHO: 50% carbohydrate, 30% fat, 20% protein) or higher in fat (FAT: 30% carbohydrate, 50% fat, 20% protein) on substrate oxidation and aerobic performance (time trial) during acute cold (5°C) exposure. Volunteers will wear shorts and a t-shirt during cold exposure, with continuous monitoring of core and skin temperatures. Baseline data will be collected on volunteer height, weight, body composition, and V̇O2peak. To ensure volunteers are familiar with exercise protocols, they will complete practice sessions of all exercise before the start of data collection. Exercise and diet will be controlled throughout data collection. 24 hours prior to data collection, volunteers will consume a lead-in study diet and will abstain from exercise. After 24 hours, volunteers will return to the laboratory for assessment of substrate oxidation and aerobic performance. Volunteers will consume the CHO or FAT treatment bars under cold conditions, followed by 60 minutes of rest prior to the start of exercise. Volunteers will then complete 90 minutes of load carriage steady-state (55 ± 5% VO2peak) treadmill exercise, wearing a ruck with weighing 30% of their total body mass. After steady-state exercise, aerobic performance will be assessed by having volunteers complete a 2-mile time trial. Indirect calorimetry will be used to determine substrate oxidation during steady-state exercise. Serial blood draws will be collected during each trial to assess circulating substrate\u002Fhormone responses. Protocol days will be separated by a minimum washout period of 6 days.",[30],[111,112,113],"endurance exercise","dietary fat","dietary carbohydrate","2026-03-18",{"date":116,"type":37},"2026-03-24",{"date":118,"type":37},"2026-02-14",{"date":120,"type":23},"2026-09-30",{"name":122,"class":123},"United States Army Research Institute of Environmental Medicine","FED",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":131,"targetDuration":4,"studyType":24,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":45},"100591311","effect-of-caffeine-on-cold-stimulated-brown-adipose-tissue-activity-100591311","NCT06978777","Effect of Caffeine on Cold-stimulated Brown Adipose Tissue Activity","ACROBAT","Inclusion Criteria:\n\n* BMI 18.5 to 25 kg\u002Fm2\n* Able to give informed consent as documented by signature\n* Moderate caffeine consumption (1 to 3 cups of coffee per day)\n* Increase of EE in response to mild cold of ≥ 5% of REE\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to caffeine\n* Concomitant medication other than prescription free analgesics (paracetamol and NSAID) and oral contraceptives\n* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, cardiac arrhythmia, hypertension, diabetes mellitus, hyper- or hypothyroidism)\n* History of depressive disorder or anxiety disorder\n* Smoker \u002F habitual tobacco use\n* Habitual excessive alcohol use\n* Regular consumption of caffeine containing energy drinks\n* Weight change of \\>5% within 3 months prior to inclusion\n* Systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\> 95 mmHg.\n* Resting heart rate \\>90 bpm\n* Hypersensitivity to cold (e.g. Raynaud syndrome)\n* Known or suspected non-compliance, drug or alcohol abuse\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.\n* Enrolment of the investigator, his\u002Fher family members, employees, and other dependent persons\n* Enrolment into another study using ionizing radiation within the previous 12 months.\n* Pregnancy or lactation",{"count":22,"type":23},[26],"The purpose of the study is to asses brown adipose tissue activity after a cold mild stimulus, preceded by 200mg caffeine or placebo administration.",[135,30],"Brown Adipose Tissue (BAT) Physiology","2026-01-22",{"date":138,"type":37},"2026-01-23",{"date":140,"type":37},"2026-01-21",{"date":142,"type":23},"2026-12-31",{"name":144,"class":44},"University Hospital, Basel, Switzerland"]