Metabolic Effects of Cryolipolysis in Overweight Individuals on a Low-Calorie Diet: A Protocol for a Randomized Controlled Trial

Articles in Press

Document Type : Protocol Study

Authors

1 Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Science, Mashhad, Iran

2 Student Research Committee, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

3 Department of radiology, Mashhad Branch, Islamic Azad University, Mashhad, Iran

4 Social Determinants of Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

5 Brighton & Sussex Medical School, Division of Medical Education, Falmer, Brighton, Sussex BN1 9PH, UK

6 Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran

7 Transplant Research Center, Clinical Research Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

8 International UNESCO Center for Health-Related Basic Sciences and Human Nutrition, Mashhad University of Medical Sciences, Mashhad, Iran.

Abstract

Introduction: Obesity, with its associated health risks, remains a major global concern. While traditional methods of weight management have their limitations, new non-invasive options, such as Cryolipolysis, have been gaining attention. Cryolipolysis is a non-invasive procedure that selectively targets and eliminates fat cells by freezing them. This study aims to investigate the metabolic effects of cryolipolysis in combination with a low-calorie diet. Methods: This randomized controlled clinical trial aims to investigate the effects of Cryolipolysis in combination with a standardized low-calorie diet in 50 overweight women aged 18-65 years. Participants will be randomly assigned to one of three groups: combination of cryolipolysis and low-calorie diet, or a low-calorie diet only. Metabolic parameters such as body composition, fat layer thickness, and various biochemical parameters, including fasting blood glucose levels, lipid profile, and renal and liver function tests profile will be measured at baseline and at the end of the study. Discussion: This study will provide valuable insights into the metabolic effects of combining cryolipolysis with a low-calorie diet. Understanding how these interventions interact at a metabolic level can inform the development of more effective weight loss strategies.

Keywords

Main Subjects

References

  1. Ofei FJGmj. Obesity-a preventable disease. 2005;39(3):98.
  2. Kazemi-Bajestani SM, Tayefi M, Ebrahimi M, Heidari-Bakavoli AR, Moohebati M, Parizadeh SM, et al. The prevalence of metabolic syndrome increases with serum high sensitivity C-reactive protein concentration in individuals without a history of cardiovascular disease: a report from a large Persian cohort. Annals of Clinical Biochemistry. 2017;54(6):644-8.
  3. Arabpour-Dahoue M, Mohammadzadeh E, Avan A, Nezafati P, Nasrfard S, Ghazizadeh H, et al. Leptin level decreases after treatment with the combination of radiofrequency and ultrasound cavitation in response to the reduction in adiposity. Diabetes & Metabolic Syndrome: Clinical Research & Reviews. 2019;13(2):1137-40.
  4. Blüher MJNRE. Obesity: global epidemiology and pathogenesis. Nature reviews endocrinology. 2019;15(5):288-98.
  5. Stefan N, Häring H-U, Hu FB, Schulze MBJTlD, endocrinology. Divergent associations of height with cardiometabolic disease and cancer: epidemiology, pathophysiology, and global implications. The lancet Diabetes & endocrinolog. 2016;4(5):457-67.
  6. Baum T, Cordes C, Dieckmeyer M, Ruschke S, Franz D, Hauner H, et al. MR-based assessment of body fat distribution and characteristics. European Journal of Radiology. 2016;85(8):1512-8.
  7. Azizian M, Mahdipour E, Mirhafez SR, Shoeibi S, Nematy M, Esmaily H, et al. Cytokine profiles in overweight and obese subjects and normal weight individuals matched for age and gender. Annals of Clinical Biochemistry. 2016;53(6):663-8.
  8. Kissebah AH, Krakower GRJPr. Regional adiposity and morbidity. Physiological reviews. 1994;74(4):761-811.
  9. Van Itallie TBJAoim. Health implications of overweight and obesity in the United States. 1985;103(6_Part_2):983-8.
  10. Rashidi AA, Bakavoli ARH, Avan A, Aghasizade M, Ghazizadeh H, Tayefi M, et al. Dietary intake and its relationship to different body mass index categories: a population-based study. Journal of Research in Health Sciences. 2018;18(4):e00426.
  11. Khedmatgozar H, Yadegari M, Khodadadegan MA, Khodabandeh AK, Ghazavi H, Esmaily H, et al. The effect of ultrasound cavitation in combination with cryolipolysis as a non-invasive selective procedure for abdominal fat reduction. Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2020;14(6):2185-9.
  12. Heymsfield SB, Wadden TA. Mechanisms, Pathophysiology, and Management of Obesity. The New England Journal of Medicine. 2017;376(3):254-66.
  13. Petridou A, Siopi A, Mougios VJM. Exercise in the management of obesity. Metabolism. 2019;92:163-9.
  14. Klein KB, Bachelor EP, Becker EV, Bowes LEJLiS, Medicine. Multiple same day cryolipolysis treatments for the reduction of subcutaneous fat are safe and do not affect serum lipid levels or liver function tests. Lasers in Surgery and Medicine.2017;49(7):640-4.
  15. Moreno‐Moraga J, Valero‐Altes T, Riquelme AM, Isarria‐Marcosy M, De La Torre JRJLiS, Medicine MTOJotASfL, et al. Body contouring by non‐invasive transdermal focused ultrasound. Lasers in Surgery and Medicine. 2007;39(4):315-23.
  16. Abdel‐Aal NM, Mostafa MS, Saweres JW, Ghait RSJLiS, Medicine. Cavitation and radiofrequency versus cryolipolysis on leptin regulation in central obese subjects: A randomized controlled study. Lasers in Surgery and Medicine. 2022;54(7):955-63.
  17. CRRC JPBJJoDiD. A double-blind randomized controlled trial evaluating the efficacy and tolerability of a topical body treatment in combination with cryolipolysis procedures. Journal of Drugs in Dermatology. 2019;18(4):342-8.
  18. Avram MM, Harry RSJLiS, Medicine MTOJotASfL, Surgery. Cryolipolysis™ for subcutaneous fat layer reduction. Lasers in Surgery and Medicine. 2009;41(10):703-8.
  19. Zelickson B, Egbert BM, Preciado J, Allison J, Springer K, Rhoades RW, et al. Cryolipolysis for noninvasive fat cell destruction: initial results from a pig model. Dermatologic Surgery.2009;35(10):1462-70.
  20. Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison JJAps. Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves. Aesthetic Plastic Surgery. 2009;33:482-8.
  21. Savacini MB, Bueno DT, Molina ACS, Lopes ACA, Silva CN, Moreira RG, et al. Effectiveness and safety of contrast cryolipolysis for subcutaneous-fat reduction. Dermatology Research and Practice. 2018;2018(1):5276528.
  22. Garibyan L, Sipprell III WH, Jalian HR, Sakamoto FH, Avram M, Anderson RRJLis, et al. Three‐dimensional volumetric quantification of fat loss following cryolipolysis. Lasers in Surgery and Medicine. 2014;46(2):75-80.
  23. Meyer PF, Furtado ACG, Morais SFT, de Araujo Neto LG, Silva RMVd, Medeiros MLJC. Effects of cryolipolysis on abdominal adiposity of women. Cryoletters. 2017;38(5):379-86.
  24. Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves. Aesthetic Plastic Surgery. 2009;33(4):482-8.
Journal of Nutrition,Fasting and Health

Articles in Press, Accepted Manuscript
Available Online from 09 July 2025

Files

History

  • Receive Date: 16 March 2025
  • Revise Date: 01 July 2025
  • Accept Date: 09 July 2025

Share

How to cite

Statistics