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Impact of WBC on Patients With Metabolic or Neurological Diseases or Fibromyalgia (WBC-MeNeFi)

Study acronym: WBC-MeNeFi
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 4, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion date: Dec 30, 2024 to Dec 30, 2025
    • Study completion date: Dec 30, 2025 to Dec 30, 2026
    v7
  2. Minor Secondary endpoints revised (34)
    • Study description expanded, about 80 words
    v6
  3. Minor Secondary endpoints: details revised at 2 of 34 entriesv5
  4. Minor Secondary endpoints: 32 to 34
    • Study title revised
    v4
  5. Notable Enrollment target: 30 to 300v3 Show 9 more changesShow less
    • Primary completion date: Apr 30, 2022 to Dec 30, 2024
    • Trial status: Completed to Recruiting
    • Study completion date: Apr 30, 2022 to Dec 30, 2025
    • Secondary endpoints: 13 to 32
    • Study description expanded, about 298 words
    • Site details revised
    • Collaborators expanded, about 8 words
    • Publications: 14 to 16
    • Study title expanded, about 5 words
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this clinical trial is to investigate on different types of patients the effects of 10 sessions of whole-body cryostimulation (WBC): 1) in patients with obesity (BMI \> 30), we want to investigate whether WBC increases thermogenesis, basal metabolic rate (BMR), respiratory quotient (which indirectly provides an estimate of energy substrate oxidation), reduces chronic inflammatory status, fatigue and pain, and improves functional abilities and general physical and psychological capacities; 2) in patients diagnosed with fibromyalgia and/or osteoarthrytis, we want to investigate the reduction of pain, inflammatory status, increase in functional capacity and general physical and psychological abilities, and improvement in mood; 3) in neurological patients diagnosed with Parkinson's disease, Multiple Sclerosis, and Disimmune Polyneuropathies, the effects of WBC on pain, fatigue, and sleep quality are to be investigated; 4) in normal/overweight (BMI\<30 kg/m2) subjects, the effects of WBC on all parameters described previously for the other protocols are to be investigated. Specifically, for all enrolled subjects, we want to assess blood catecholamine levels, investigate the effects of sympathetic response on body composition, blood pressure, heart rate, lipid profile, and physical performance. Three hundred patients admitted for a rehabilitation program (diet + physiotherapy + exercise) will be non-randomly assigned to either a group following the program (R) or a group additionally receiving ten 2-3 minute WBC sessions at -110°C over two weeks (RWBC).
Trial Details
NCT Number NCT05443100
Lead Sponsor Istituto Auxologico Italiano
Collaborators: Politecnico di Milano, Università degli Studi di Brescia
Conditions
(from sponsor)
Obesity, Fibromyalgia, Neurological Conditions
Related terms Fibromyalgia, Obesity
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov