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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03462537
Other study ID # AN-006
Secondary ID
Status Terminated
Phase N/A
First received March 6, 2018
Last updated March 6, 2018
Start date November 20, 2016
Est. completion date June 20, 2017

Study information

Verified date March 2018
Source Escola Superior de Tecnologia da Saúde do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the present study was to evaluate the effects of one session of aerobic exercise associated with low level laser therapy in lipolytic activity, lipid profile and inflammatory markers (C-reactive protein - CRP).


Description:

The adipose tissue is the main energetic reserve, being constituted by adipocytes, cells that accumulate lipids inside its cytoplasm, in the form of triglycerides.

Fat deposition can occur both in the subcutaneous compartment and in the visceral compartment and is the result of a positive energy balance in which there is an imbalance between the amount of calories consumed and the amount of calories expended. Thus, an excess of energy storage occurs in the form of triglycerides in adipose tissue, which results from a sedentary lifestyle and a diet based on lipid rich nutrients. When fat deposition occurs in abdominal adipose tissue may favor the development of metabolic disorders.

Recently the effectiveness of an innovative physiotherapeutic intervention - low power laser therapy (LLLT) - on adipose tissue has been studied. This therapeutic modality stimulates cytochrome C oxidase, causing the release of nitric oxide, increased mitochondrial membrane potential and adenosine triphosphate (ATP) synthesis and the transient increase of reactive oxygen species (ROS). It is proposed that ROS creates temporary pores in the adipocyte membrane, allowing the release of its lipid content. It is also suggested that a regulation of cAMP occurs, which stimulates the lipolytic cascade, converting the triglycerides to fatty acids and glycerol. In this way, low level laser therapy seems to aid in the reduction of adiposity and in the decrease of cholesterol and triglycerides serum levels . In addition, it assists in the reduction of the inflammatory process related to obesity, by reducing the pro-inflammatory cytokines.

The aerobic exercise, due to its low-moderate intensity, enhances the stimulation of lipolysis, by decreasing plasma insulin concentration and elevating the level of catecholamines. In this way, it influences the lipid metabolism, seeming to improve the lipid profile, through the degradation of the triglycerides as energetic substrate. In addition, the regular practice of physical exercise seems to promote a decrease in the inflammation state due to metabolic changes, through the reduction of pro-inflammatory cytokines, namely interleukin-6 and, consequently, C-reactive protein.

The application of low level laser therapy in the abdominal region enhances the release of fat acids and glycerol into the bloodstream, increasing the availability of the substrate for muscle energy consumption. However, if they are not used as energy, free circulating fat acids may bind to glycerol and potentiate, again, the accumulation of triglycerides in abdominal adipocytes. Thus, aerobic exercise seems to be a good option in the fight against this re-esterification, since it is expected that the resulting fat acids will be converted to acetyl-CoA, entering the Krebs cycle, being used as energy source during aerobic exercise.


Recruitment information / eligibility

Status Terminated
Enrollment 36
Est. completion date June 20, 2017
Est. primary completion date May 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- age between 18 and 25 years.

- BMI between 18,5Kg/m2 and 29,9Kg/m2

- consider presenting abdominal fat

Exclusion Criteria:

- pregnant or intending to be in a period of 9 months

- participants with smoking habits

- participants with neoplasias, metabolic dysfunctions, renal pathologies, dermatological alterations

- participants with electronic devices

- participants with a condition that makes it impossible to practice physical exercise (disabling skeletal muscle pathologies and severe cardiorespiratory pathologies)

- participants under the effect of beta-blockers or other drugs which influence heart rate

- participants submitted to other fat reduce procedure

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Low level laser therapy
Low level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes.
Aerobic Exercise
Aerobic exercise protocol - 50 minutes of aerobic moderate-intensity exercise (45-55% of reserve heart rate) using Karvonen´s formula, performed on a cycloergometer. The duration of the exercise was divided into three parts: warm-up (from 0 to 5 minutes); body (from 5 to 45 minutes); and cooling (from 45 to 50 minutes). The entire protocol was monitored through the Polar® brand cardiofrequency and watch.
Low level laser therapy without power
Low level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes. In this group low level laser therapy device was switched off.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Escola Superior de Tecnologia da Saúde do Porto

References & Publications (28)

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Ahmadian M, Wang Y, Sul HS. Lipolysis in adipocytes. Int J Biochem Cell Biol. 2010 May;42(5):555-9. doi: 10.1016/j.biocel.2009.12.009. Epub 2009 Dec 16. Review. — View Citation

Aquino AE Jr, Sene-Fiorese M, Castro CA, Duarte FO, Oishi JC, Santos GC, Silva KA, Fabrizzi F, Moraes G, Matheus SM, Duarte AC, Bagnato VS, Parizotto NA. Can low-level laser therapy when associated to exercise decrease adipocyte area? J Photochem Photobiol B. 2015 Aug;149:21-6. doi: 10.1016/j.jphotobiol.2015.04.033. Epub 2015 May 20. — View Citation

Aquino Junior, A. E. (2012). Efeito do laser de baixa intensidade (830nm) associado ao exercício em ratos obesos exógenos. São Carlos: Universidade Federal de São Carlos

Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg. 2013 Mar;32(1):41-52. Review. — View Citation

Avci P, Nyame TT, Gupta GK, Sadasivam M, Hamblin MR. Low-level laser therapy for fat layer reduction: a comprehensive review. Lasers Surg Med. 2013 Aug;45(6):349-57. doi: 10.1002/lsm.22153. Epub 2013 Jun 7. Review. — View Citation

Brown SA, Rohrich RJ, Kenkel J, Young VL, Hoopman J, Coimbra M. Effect of low-level laser therapy on abdominal adipocytes before lipoplasty procedures. Plast Reconstr Surg. 2004 May;113(6):1796-804; discussion 1805-6. — View Citation

Cavalheiro, C., Ferreira, A., & Assunção, F. (2012). O uso da eletrolipólise no tratamento da adiposidade localizada. Revisão integrativa. Ensaios e Ciência: Ciências Biológicas, Agrárias e da Saúde, 16(3), 157-165.

Costa, A., Eberlin, S., Jorge, A., Mendonça, J., Kalies, A., & Pereira, C. (2014). Clinical study to assess abdominal circumferential reduction after treatment with lowfrequency. Surgical And Cosmetic Dermatology, 6(4), 320-324.

da Silveira Campos RM, Dâmaso AR, Masquio DC, Aquino AE Jr, Sene-Fiorese M, Duarte FO, Tock L, Parizotto NA, Bagnato VS. Low-level laser therapy (LLLT) associated with aerobic plus resistance training to improve inflammatory biomarkers in obese adults. Lasers Med Sci. 2015 Jul;30(5):1553-63. doi: 10.1007/s10103-015-1759-9. Epub 2015 May 10. — View Citation

de Ferranti S, Mozaffarian D. The perfect storm: obesity, adipocyte dysfunction, and metabolic consequences. Clin Chem. 2008 Jun;54(6):945-55. doi: 10.1373/clinchem.2007.100156. Epub 2008 Apr 24. Review. — View Citation

Donges CE, Duffield R, Drinkwater EJ. Effects of resistance or aerobic exercise training on interleukin-6, C-reactive protein, and body composition. Med Sci Sports Exerc. 2010 Feb;42(2):304-13. doi: 10.1249/MSS.0b013e3181b117ca. — View Citation

Elm CM, Wallander ID, Endrizzi B, Zelickson BD. Efficacy of a multiple diode laser system for body contouring. Lasers Surg Med. 2011 Feb;43(2):114-21. doi: 10.1002/lsm.21016. Erratum in: Lasers Surg Med. 2011 Sep;43(7):781-2. — View Citation

Glisezinski, & I. (2007). Mobilisation des lipides du tissu adipeux au cours de l'exercice physique. Science & Sports, 22(6), 280-285. doi:10.1016/j.scispo.2007.09.013

Horowitz JF. Fatty acid mobilization from adipose tissue during exercise. Trends Endocrinol Metab. 2003 Oct;14(8):386-92. Review. — View Citation

Jackson, R. F., Roche, G. C., & Wisler, K. (2010). Reduction in Cholesterol and Triglyceride Serum Levels Following Low-Level Laser Irradiation: A Noncontrolled, Nonrandomized Pilot Study. The American Journal of Cosmetic Surgery, 27, 177-184.

Karu T. Photobiology of low-power laser effects. Health Phys. 1989 May;56(5):691-704. Review. — View Citation

Karu TI, Afanas'eva NI. [Cytochrome c oxidase as the primary photoacceptor upon laser exposure of cultured cells to visible and near IR-range light]. Dokl Akad Nauk. 1995 Jun;342(5):693-5. Russian. — View Citation

Karu TI. Mitochondrial signaling in mammalian cells activated by red and near-IR radiation. Photochem Photobiol. 2008 Sep-Oct;84(5):1091-9. doi: 10.1111/j.1751-1097.2008.00394.x. Epub 2008 Jul 18. Review. — View Citation

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. Review. — View Citation

Lafontan M, Langin D. Lipolysis and lipid mobilization in human adipose tissue. Prog Lipid Res. 2009 Sep;48(5):275-97. doi: 10.1016/j.plipres.2009.05.001. Epub 2009 May 21. Review. — View Citation

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. Review. — View Citation

Neira R, Arroyave J, Ramirez H, Ortiz CL, Solarte E, Sequeda F, Gutierrez MI. Fat liquefaction: effect of low-level laser energy on adipose tissue. Plast Reconstr Surg. 2002 Sep 1;110(3):912-22; discussion 923-5. — View Citation

Nestor MS, Zarraga MB, Park H. Effect of 635nm Low-level Laser Therapy on Upper Arm Circumference Reduction: A Double-blind, Randomized, Sham-controlled Trial. J Clin Aesthet Dermatol. 2012 Feb;5(2):42-8. — View Citation

Powers, S. K., & Howley, E. T. (2004). Fisiologia do Exercício - Teoria e Aplicação ao Condicionamento e ao Desempenho (5ª ed.). Brasil: Manole.

Rosenbaum M, Prieto V, Hellmer J, Boschmann M, Krueger J, Leibel RL, Ship AG. An exploratory investigation of the morphology and biochemistry of cellulite. Plast Reconstr Surg. 1998 Jun;101(7):1934-9. — View Citation

Stewart LK, Flynn MG, Campbell WW, Craig BA, Robinson JP, Timmerman KL, McFarlin BK, Coen PM, Talbert E. The influence of exercise training on inflammatory cytokines and C-reactive protein. Med Sci Sports Exerc. 2007 Oct;39(10):1714-9. — View Citation

Tafur J, Mills PJ. Low-intensity light therapy: exploring the role of redox mechanisms. Photomed Laser Surg. 2008 Aug;26(4):323-8. doi: 10.1089/pho.2007.2184. — View Citation

* Note: There are 28 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in glycerol concentration Blood analysis collection was carried out with help from an clinical analysis technician. 10 minutes before the intervention and 5 minutes after the intervention
Primary Change in CRP concentration Blood analysis collection was carried out with help from an clinical analysis technician. 10 minutes before the intervention and 5 minutes after the intervention
Primary Change in lipid profile (LDL, HDL and triglyceride concentrations) Blood analysis collection was carried out with help from an clinical analysis technician. 10 minutes before the intervention and 5 minutes after the intervention
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