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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance exercise training plus hypocaloric diet | Experimental | The participants received a caloric restriction of 20% of total energy estimated with Mifflin formula plus a structured, planned, and controlled resistance exercise program by a personal trained. The participant received the exercise program instructions every week and they performed by the own, and record the heart rate of each session on a paper format. All the appointment were once a month by trained nutritionists, and all the participants received a nutritional recommendation for the obesity management and a balanced food plan. |
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| Hypocaloric diet | Active Comparator | The participants received a caloric restriction of 20% of total energy estimated with Mifflin formula. All the appointment were once a month by trained nutritionists, and all the subjects received a nutritional recommendation for the obesity management and a balanced food plan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance exercise training plus hypocaloric diet | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| NLRP3 gene expression | Assay expression will be performed by real-time PCR using Taqman probes with the 2-ΔΔcq relative quantification method | Change from baseline NLRP3 gene expression at 3 months |
| IL-18 gene expression | Assay expression will be performed by real-time PCR using Taqman probes with the 2-ΔΔcq relative quantification method | Change from baseline IL-18 gene expression at 3 months |
| IL-18 cytokine | commercial ELISA kit | Change from baseline IL-18 cytokine at 3 months |
| IL-1b cytokine | commercial ELISA kit | Change from baseline IL-1b cytokine at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weighing machine using bioimpedance technology | Change from baseline weight at 3 months |
| Body fat mass | Weighing machine using bioimpedance technology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Vega, PhD | Contact | +526677545353 | melissa.vega@uas.edu.mx | |
| Marcela Vergara, PhD | Contact | +526677545353 | mjvergara@uas.edu.mx |
| Name | Affiliation | Role |
|---|---|---|
| Elisa Barron, PhD | Autonomous University of Sinaloa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Autonomous University of Sinaloa | Recruiting | Culiacán | Sinaloa | 80019 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32249021 | Background | 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. | |
| 26040339 | Background | 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. Spanish. |
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We reserve to respect the individual rights of not revealing personal data of the participants, since this information is signing in the informed consent. However, we will publish all the results on a manuscript.
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D007249 | Inflammation |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
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Experimental
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| Hypocaloric diet | Behavioral | 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). |
|
| Change from baseline body fat mass at 3 months |
| Serum triglycerides | Liquid chemistry using spectrum equipment | Change from baseline serum triglycerides at 3 months |
| Serum cholesterol | Liquid chemistry using spectrum equipment | Change from baseline serum cholesterol at 3 months |
| Serum glucose | Liquid chemistry using spectrum equipment | Change from baseline serum glucose at 3 months |
| 25653548 | Background | 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. |
| 15070939 | Background | 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. doi: 10.1210/jc.2003-031310. |
| 32854610 | Result | Barron-Cabrera E, Gonzalez-Becerra K, Rosales-Chavez G, Mora-Jimenez A, Hernandez-Canaveral I, Martinez-Lopez E. Low-grade chronic inflammation is attenuated by exercise training in obese adults through down-regulation of ASC gene in peripheral blood: a pilot study. Genes Nutr. 2020 Aug 27;15(1):15. doi: 10.1186/s12263-020-00674-0. |
| 29683921 | Result | 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. |
| 20200803 | Result | 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. |
| D044343 |
| Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |