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Intermittent Cold Exposure and Brown Adipose Tissue Hyperplasia

Study acronym: ICEBATH
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion pushed from Jul 2026 to Jul 2027v4
  2. Re-verified, no change to tracked fieldsv3
  3. Primary endpoint revised Interventions: Biopsies (Procedure), Cooling (Other), Injection of 18F-FDG (Radiation) to Biopsies (Procedure), Cooling (Other), Core and skin temperature monitoring (Other), Electromyogram (Other), Indirect calorimetry (Other)… · Secondary endpoints revised (4) · Study description expanded, about 99 wordsv2 Show 3 more changesShow less
    • Interventions: Biopsies (Procedure), Cooling (Other), Injection of 18F-FDG (Radiation) to Biopsies (Procedure), Cooling (Other), Core and skin temperature monitoring (Other), Electromyogram (Other), Indirect calorimetry (Other)…
    • Secondary endpoints revised (4)
    • Study description expanded, about 99 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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/computed tomography (PET/CT) scans, the molecular adaptations within BAT and other thermogenic tissues including skeletal muscle and white adipose tissue (WAT) remain poorly understood. Healthy 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. Participants 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/CT 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.
Trial Details
NCT Number NCT07048405
Lead Sponsor University of Edinburgh
Conditions Brown Adipose Tissue, Cold Exposure, 18F-FDG PET/CT
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov