The Association of Resistance Exercise With the Inflammasome Activation in Obesity Subjects

Obesity Clinical Trial

Official title:

The Potential Role of Resistance Exercise on Inflammasome Activation and Cytokines Levels in Obese Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05482178
• Other study ID #: CE-FCNYG-2022-FEB-001
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: July 2022
• Source: Universidad Autónoma de Sinaloa
• Contact: Melissa Vega, PhD
• Phone: +526677545353
• Email: melissa.vega[@]uas.edu.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The intervention study consist in 3 months of follow up to evaluate the effect of resistance exercise on NLRP3 and interleukin-18 (IL-18) gene expression, and IL-18 and IL-1b cytokines levels in obese subjects, due to, the current evidence has been suggested that aerobic physical exercise could reduce the low-grade chronic inflammation through the downregulation of the NLRP3 inflammasome in obesity subjects, however, there are not enough evidence with resistance protocol. The investigator randomized into two intervention groups: a) group with resistance exercise training plus hypocaloric diet, and b) group with hypocaloric diet. The blood sample was taken fasting at baseline and final intervention (3rd month). The serum was separated for biochemical analyzes and the quantification of cytokines levels. The RNA was obtained from leukocytes to expression assay.

Description:

Obesity is a metabolic condition with a high worldwide prevalence. It is characterized by low-grade chronic inflammation and high cytokines level as consequence of the excessive accumulation of adipose tissue. The NLRP3 protein is part of the NLRP3 inflammasome, a multiprotein complex related to inflammation and the risk of developing metabolic disorders. In this sense, the evidence has been suggested that physical exercise could reduce the inflammation through the downregulation of the NLRP3 inflammasome. The aim of this study is evaluate the effect of resistance exercise on NLRP3 and IL-18 gene expression and and IL-18 and IL-1b cytokines levels in obese subjects. This is an experimental study with 3 months of follow up. Participants were randomized into two intervention groups: a) group with resistance exercise plus hypocaloric diet, and b) group with hypocaloric diet. The exercise program was design by certified personal trained, and consisted in 3 phases: conditioning, development and maintenance. Dietary information was collect by validated retrospective questionnaires (24-hour record and 3-days dietary diary) and analyzed in Nutritionist Pro software. Body composition was evaluated by bioimpedance. The biochemical analyzes were performed on serum sample using spectrophotometry equipment. RNA was obtained from leukocytes from peripheral blood, cDNA synthesis was performed with a ThermoFisher kit, and the expression assay was performed by real-time polymerase chain reaction (PCR) using Taqman probes with the 2-ΔΔcq relative quantification method. Cytokines quantification were perform using a commercial ELISA kit. Statistical analysis will be using the Statistical Package for Social Sciences (SPSS v.25) software and a value of p<0.05 will be considered statistically significant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 16, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Both sex
• Older than 25 years old
• Women with waist circumference = 80cm and men with = 90cm
• Subjects with BMI between 30 and 40 kg/m2

Exclusion Criteria:

• Subjects with diagnosis of metabolic alterations
• Subjects with chronic pharmacological treatment
• Subjects with anti-inflammatories drugs prescription

Related Conditions & MeSH terms

• Inflammation
• Obesity
• Physical Activity
• Resistance Exercise

Intervention

Behavioral:
• Resistance exercise training plus hypocaloric diet
The exercise program included 3 phases of progressive intervention: 1) Adaptation which included 3-4 days per week at 60% of maximum heart rate, 2) Development phase which included 5 days per week at 75-85% of maximum heart rate and the last one, 3) Maintenance phase which included 5 days per week at 75-90% of maximum heart rate. The control and follow up will be through text message exchanges at least once a week or as many as necessary. On the other hand, the diet intervention consisted a caloric restriction of 20% of total energy estimated with Mifflin formula. The nutrients distributions are 50% for carbohydrates, 20% for protein and 30% for lipids, ensuring a sufficient intake of fiber (>25g per day).
• Hypocaloric diet
The diet intervention consisted a caloric restriction of 20% of total energy estimated with Mifflin formula. The nutrients distributions are 50% for carbohydrates, 20% for protein and 30% for lipids, ensuring a sufficient intake of fiber (>25g per day).

Locations

Country	Name	City	State
Mexico	Autonomous University of Sinaloa	Culiacán	Sinaloa

Sponsors (1)

Lead Sponsor	Collaborator
Elisa Barron-Cabrera

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

Barrón-Cabrera E, González-Becerra K, Rosales-Chávez G, Mora-Jiménez A, Hernández-Cañaveral I, Martínez-López E. Low-grade chronic inflammation is attenuated by exercise training in obese adults through down-regulation of ASC gene in peripheral blood: a p — View Citation

Butts B, Butler J, Dunbar SB, Corwin E, Gary RA. Effects of Exercise on ASC Methylation and IL-1 Cytokines in Heart Failure. Med Sci Sports Exerc. 2018 Sep;50(9):1757-1766. doi: 10.1249/MSS.0000000000001641. — View Citation

Izaola O, de Luis D, Sajoux I, Domingo JC, Vidal M. [Inflammation and obesity (lipoinflammation)]. Nutr Hosp. 2015 Jun 1;31(6):2352-8. doi: 10.3305/nh.2015.31.6.8829. Review. Spanish. — View Citation

Metsios GS, Moe RH, Kitas GD. Exercise and inflammation. Best Pract Res Clin Rheumatol. 2020 Apr;34(2):101504. doi: 10.1016/j.berh.2020.101504. Epub 2020 Apr 2. Review. — View Citation

Nakajima K, Takeoka M, Mori M, Hashimoto S, Sakurai A, Nose H, Higuchi K, Itano N, Shiohara M, Oh T, Taniguchi S. Exercise effects on methylation of ASC gene. Int J Sports Med. 2010 Sep;31(9):671-5. doi: 10.1055/s-0029-1246140. Epub 2010 Mar 3. — View Citation

Ozaki E, Campbell M, Doyle SL. Targeting the NLRP3 inflammasome in chronic inflammatory diseases: current perspectives. J Inflamm Res. 2015 Jan 16;8:15-27. doi: 10.2147/JIR.S51250. eCollection 2015. Review. — View Citation

You T, Berman DM, Ryan AS, Nicklas BJ. Effects of hypocaloric diet and exercise training on inflammation and adipocyte lipolysis in obese postmenopausal women. J Clin Endocrinol Metab. 2004 Apr;89(4):1739-46. Erratum in: J Clin Endocrinol Metab.2004 Jun;89(6):2972. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NLRP3 gene expression	Assay expression will be performed by real-time PCR using Taqman probes with the 2-??cq relative quantification method	Change from baseline NLRP3 gene expression at 3 months
Primary	IL-18 gene expression	Assay expression will be performed by real-time PCR using Taqman probes with the 2-??cq relative quantification method	Change from baseline IL-18 gene expression at 3 months
Primary	IL-18 cytokine	commercial ELISA kit	Change from baseline IL-18 cytokine at 3 months
Primary	IL-1b cytokine	commercial ELISA kit	Change from baseline IL-1b cytokine at 3 months
Secondary	Weight	Weighing machine using bioimpedance technology	Change from baseline weight at 3 months
Secondary	Body fat mass	Weighing machine using bioimpedance technology	Change from baseline body fat mass at 3 months
Secondary	Serum triglycerides	Liquid chemistry using spectrum equipment	Change from baseline serum triglycerides at 3 months
Secondary	Serum cholesterol	Liquid chemistry using spectrum equipment	Change from baseline serum cholesterol at 3 months
Secondary	Serum glucose	Liquid chemistry using spectrum equipment	Change from baseline serum glucose at 3 months