NCT05443100 Impact of WBC on Patients With Metabolic or Neurological Diseases or Fibromyalgia (WBC-MeNeFi)
| NCT ID | NCT05443100 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Auxologico Italiano |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2019-04-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2019-04-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * both sexes * age 18-65 yrs * BMI \> 35 kg/m2 Exclusion Criteria: * severe psychiatric conditions * acute respiratory disease * acute cardiovascular disease * unstable hypertension * cold intolerance * claustrophobia * pregnancy * recent modification of usual drug treatment * previous treatment with WBC * weight loss in the last 3 months * body temperature greater than 37.5°C.
Contact & Investigator
Paolo Capodaglio, Prof, MD
PRINCIPAL INVESTIGATOR
IRCCS Istituto Auxologico Italiano
Frequently Asked Questions
Who can join the NCT05443100 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05443100 currently recruiting?
Yes, NCT05443100 is actively recruiting participants. Contact the research team at p.capodaglio@auxologico.it for enrollment information.
Where is the NCT05443100 trial being conducted?
This trial is being conducted at Oggebbio, Italy.
Who is sponsoring the NCT05443100 clinical trial?
NCT05443100 is sponsored by Istituto Auxologico Italiano. The principal investigator is Paolo Capodaglio, Prof, MD at IRCCS Istituto Auxologico Italiano. The trial plans to enroll 300 participants.
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