NCT04287153

Cryotherapy and Body Slimming

Evaluation of the Effectiveness of Cryotherapy in Slimming of the Abdomen and Saddlebags

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Clinic Cryo Esthetic · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy of cryotherapy on the slimming of subcutaneous fat mass in the abdomen and saddlebags. Cryotherapy is a completely non-invasive method that induces a selective reduction of fat cells by localized and controlled cooling in areas such as the abdomen, flanks, inner knees, inner thighs, back and arms. Adipose tissue is composed of two types of tissue: white and brown adipose tissue. Studies have shown that exposure to cold induces an increase in the number of brown adipocytes (detected by PET/CT-scan) under the effect of the hormone irisin produced by the muscles. In addition, another study has shown that prolonged exposure to cold reduces the size of brown adipocytes leading to thermogenesis, suggesting that cold exposure may contribute to the control of obesity. The freezing technology of this cryotherapy unit allows the temperature of the subcutaneous adipose tissue to move almost instantaneously from -6°C to -10°C, gradually causing the reduction of subcutaneous adipose tissue.

Detailed description

Prospective, monocentric pilot and comparative (before and after) study in simple blind (assessor different from the operator). * The effectiveness of cryotherapy will be evaluated by the metric measurement of the treated areas: waist circumference, from the hips to the level of the saddlebags. * Measurement of subcutaneous fat mass with iDXA scanner on treated areas * Metabolic parameters from a blood test: Liver function (AST, ALT, gamma GT), inflammatory markers, plasmatic fatty acids, glycerol, total cholesterol, triglycerides, lipids, blood sugar, insulin, lactate.

Conditions

• Obesity
• Cryotherapy Effect
• Weight Loss

Interventions

Type	Name	Description
DEVICE	Cryotherapy on abdomen and saddlebags	Application of variable temperature (-10°c to -7°c) on the treated areas using the cryotherapy device FG660L-006 (Beijing ADSS Development CO., Ltd)

Timeline

• Start date: 2017-09-17
• Primary completion: 2018-04-22
• Completion: 2018-09-17
• First posted: 2020-02-27
• Last updated: 2020-02-27

Locations

1 site across 1 country: France