NCT05443100: WBC-MeNeFi

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

Recruiting now NA Last updated 4 August 2025

What this trial tests

NA trial testing Whole-body cryostimulation (WBC) in Obesity in 300 participants. Currently enrolling.

Timeline

1 April 2019

Primary endpoint
30 December 2025

30 December 2026

Quick facts

Lead sponsor	Istituto Auxologico Italiano
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	basic science
Enrollment	300
Start date	1 April 2019
Primary completion	30 December 2025
Estimated completion	30 December 2026
Sites	1 location across Italy

Drugs / interventions tested

• Whole-body cryostimulation (WBC)
• Rehabilitation program

Conditions studied

• Obesity — all drugs for Obesity →
• Fibromyalgia — all drugs for Fibromyalgia →
• Neurological Conditions — all drugs for Neurological Conditions →

Sponsor

Istituto Auxologico Italiano — full company profile →

Who can join

Adults 18 to 65, any sex, with Obesity or Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Whole-Body Cryostimulation: An Effective Complementary Treatment in Fibromyalgia? A Follow Up Study.
   Verme F, Majdič N, Modaffari G, Alito A, et al · · 2024 · cited 4× · PMID 39202027 · DOI 10.3390/jpm14080836
2. Autonomic Modulation in Parkinson's Disease Using Whole-Body Cryostimulation: A Pilot Study.
   Piterà P, Cremascoli R, Bianchi L, Borghesi F, et al · · 2024 · cited 2× · PMID 39595033 · DOI 10.3390/biomedicines12112467
3. Effects of whole-body cryostimulation on spinal and shoulder range of motion in individuals with obesity.
   Cerfoglio S, Verme F, Fontana JM, Alito A, et al · · 2025 · cited 1× · PMID 40772266 · DOI 10.3389/fresc.2025.1568280
4. Effects of Whole-Body Cryostimulation on Stress Biomarkers and Psychological Well-Being in Parkinson’s Disease: A Pilot Study
   Piterà P, Cattaldo S, Cremascoli R, Bianchi L, et al · · 2026
5. Sex and Body Mass Index Differences in Changes in Skin Temperature After Repeated Sessions of Whole-Body Cryostimulation.
   Piterà P, Cancello R, Fontana JM, Verme F, et al · · 2024 · PMID 39685822 · DOI 10.3390/jcm13237365