Cryotherapy and Body Slimming

NCT04287153 | Completed

• 1 other identifier: 2017-A01278-45
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Cryotherapy Effect; Weight Loss

Keywords

obesity; cryotherapy; weight loss; saddlebags

Outcome Measures

Primary Outcomes (2)

• Metric measurements of the treated areas (cm)

  The effectiveness of cryotherapy will be evaluated by the metric measurement of the treated areas: waist circumference, from the hips to the horse's breeches.

  15 days after treatment

• Metric measurements of the treated areas (cm)

  The effectiveness of cryotherapy will be evaluated by the metric measurement of the treated areas: waist circumference, from the hips to the horse's breeches.

  3 months after treatment

Secondary Outcomes (7)

• iDXA scanner measurement

  15 days

• iDXA scanner measurement

  3 months

• Metabolic assessment

  15 days after treatment

• Metabolic assessment

  15 days after treatment

• Metabolic assessment

  15 days after treatment

Study Arms (1)

Croytherapy on abdomen and saddlebags

EXPERIMENTAL

Six (6) to 10 applicators (application area of 17 cm X 6 cm) are applied on the dorsal side (back, waist, saddlebags) for 45 minutes and then on the ventral side (belly) for 45 minutes, with adjustments according to the size of the participant. The temperature applied with the device is variable (-10°c to -7°C).

Device: Cryotherapy on abdomen and saddlebags

Interventions

Cryotherapy on abdomen and saddlebags DEVICE

Application of variable temperature (-10°c to -7°c) on the treated areas using the cryotherapy device FG660L-006 (Beijing ADSS Development CO., Ltd)

Croytherapy on abdomen and saddlebags

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients ≥ 18 years old and non-menopausal with a BMI between 20 and 30 (20≥IMC≤30), with an overload of abdominal subcutaneous fat tissue and at the saddlebags

You may not qualify if:

• \- \< 18 years old.
• Pregnancy
• Breastfeeding
• Cold allergy: 2-minute ice cube test positive
• A waist/hip ratio indicative of a pathological fat distribution (\>0.8 for women, \>0.9 for men)
• Endocrine pathologies (Cushing's disease, endocrine tumours, unbalanced frank or labile hypothyroidism, hirsutism and hyper-androgenism, insulin resistance and/or unbalanced type 2 diabetes...)
• Neoplasia
• Psychiatric pathologies with or without treatment (Antidepressants, Neuroleptics, Anxiolytics...), well characterized anorexia-bulimia syndromes.
• Established alcoholism. Daily alcohol consumption should not exceed 2 glasses of wine per day.
• Digestive pathologies (especially hepatic) and functional digestive disorders (chronic constipation, alternating constipation-diarrhoea, chronic abdominal pain).
• Weaknesses of the abdominal wall (umbilical, inguinal, crural hernias)
• HIV in therapy
• Genetic deformities and diseases
• Vegetarian/vegetarian diet, macrobiotic diet
• Spasmophilia

Sponsors & Collaborators

• Clinic Cryo Esthetic: lead

Study Sites (1)

Cryoesthetic

Paris, 75007, France

Location

Related Publications (13)

• Aronne LJ. Epidemiology, morbidity, and treatment of overweight and obesity. J Clin Psychiatry. 2001;62 Suppl 23:13-22.

  PMID: 11603881 RESULT

• Kennedy J, Verne S, Griffith R, Falto-Aizpurua L, Nouri K. Non-invasive subcutaneous fat reduction: a review. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1679-88. doi: 10.1111/jdv.12994. Epub 2015 Feb 9.

  PMID: 25664493 RESULT

• Avram MM, Harry RS. Cryolipolysis for subcutaneous fat layer reduction. Lasers Surg Med. 2009 Dec;41(10):703-8. doi: 10.1002/lsm.20864.

  PMID: 20014262 RESULT

• Mulholland RS, Paul MD, Chalfoun C. Noninvasive body contouring with radiofrequency, ultrasound, cryolipolysis, and low-level laser therapy. Clin Plast Surg. 2011 Jul;38(3):503-20, vii-iii. doi: 10.1016/j.cps.2011.05.002.

  PMID: 21824546 RESULT

• Bernstein EF. Longitudinal evaluation of cryolipolysis efficacy: two case studies. J Cosmet Dermatol. 2013 Jun;12(2):149-52. doi: 10.1111/jocd.12036.

  PMID: 23725309 RESULT

• van der Lans AA, Wierts R, Vosselman MJ, Schrauwen P, Brans B, van Marken Lichtenbelt WD. Cold-activated brown adipose tissue in human adults: methodological issues. Am J Physiol Regul Integr Comp Physiol. 2014 Jul 15;307(2):R103-13. doi: 10.1152/ajpregu.00021.2014.

  PMID: 24871967 RESULT

• Lee P, Swarbrick MM, Ho KK. Brown adipose tissue in adult humans: a metabolic renaissance. Endocr Rev. 2013 Jun;34(3):413-38. doi: 10.1210/er.2012-1081. Epub 2013 Apr 2.

  PMID: 23550082 RESULT

• Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson RR. Selective cryolysis: a novel method of non-invasive fat removal. Lasers Surg Med. 2008 Nov;40(9):595-604. doi: 10.1002/lsm.20719.

  PMID: 18951424 RESULT

• Zelickson B, Egbert BM, Preciado J, Allison J, Springer K, Rhoades RW, Manstein D. Cryolipolysis for noninvasive fat cell destruction: initial results from a pig model. Dermatol Surg. 2009 Oct;35(10):1462-70. doi: 10.1111/j.1524-4725.2009.01259.x. Epub 2009 Jul 13.

  PMID: 19614940 RESULT

• Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves. Aesthetic Plast Surg. 2009 Jul;33(4):482-8. doi: 10.1007/s00266-008-9286-8. Epub 2009 Mar 19.

  PMID: 19296153 RESULT

• Dierickx CC, Mazer JM, Sand M, Koenig S, Arigon V. Safety, tolerance, and patient satisfaction with noninvasive cryolipolysis. Dermatol Surg. 2013 Aug;39(8):1209-16. doi: 10.1111/dsu.12238. Epub 2013 May 2.

  PMID: 23639062 RESULT

• Garibyan L, Sipprell WH 3rd, Jalian HR, Sakamoto FH, Avram M, Anderson RR. Three-dimensional volumetric quantification of fat loss following cryolipolysis. Lasers Surg Med. 2014 Feb;46(2):75-80. doi: 10.1002/lsm.22207. Epub 2013 Dec 3.

  PMID: 24535759 RESULT

• Saarelainen J, Hakulinen M, Rikkonen T, Kroger H, Tuppurainen M, Koivumaa-Honkanen H, Honkanen R, Hujo M, Jurvelin JS. Cross-Calibration of GE Healthcare Lunar Prodigy and iDXA Dual-Energy X-Ray Densitometers for Bone Mineral Measurements. J Osteoporos. 2016;2016:1424582. doi: 10.1155/2016/1424582. Epub 2016 Apr 27.

  PMID: 27239366 RESULT

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Suva Loap, MD

  Cryoesthetic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Assessment of the effectiveness and tolerance of cryotherapy in the thinning of the abdomen and saddelbags

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 27, 2020
• Study Start: September 17, 2017
• Primary Completion: April 22, 2018
• Study Completion: September 17, 2018
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

FR (1)