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

NCT05482178 | Unknown DMC

• 1 other identifier: CE-FCNYG-2022-FEB-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Activity; Resistance Exercise; Inflammation; Obesity

Keywords

Resistance training; inflammasome; Obesity

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• Weight

  Change from baseline weight at 3 months

• Body fat mass

  Change from baseline body fat mass at 3 months

• Serum triglycerides

  Change from baseline serum triglycerides at 3 months

• Serum cholesterol

  Change from baseline serum cholesterol at 3 months

• Serum glucose

  Change from baseline serum glucose at 3 months

Study Arms (2)

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.

Behavioral: Resistance exercise training plus hypocaloric diet

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.

Behavioral: Hypocaloric diet

Interventions

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).

Resistance exercise training plus hypocaloric diet

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).

Hypocaloric diet

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Elisa Barron-Cabrera: lead

Study Sites (1)

Autonomous University of Sinaloa

Culiacán, Sinaloa, 80019, Mexico

RECRUITING

Related Publications (7)

• 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.

  PMID: 32249021 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.

  PMID: 26040339 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.

  PMID: 25653548 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.

  PMID: 15070939 BACKGROUND

• 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.

  PMID: 32854610 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.

  PMID: 29683921 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.

  PMID: 20200803 RESULT

MeSH Terms

Conditions

Motor Activity; Inflammation; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Elisa Barron, PhD

  Autonomous University of Sinaloa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Vega, PhD

CONTACT

+526677545353; melissa.vega@uas.edu.mx

Marcela Vergara, PhD

CONTACT

+526677545353; mjvergara@uas.edu.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Experimental

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 1, 2022
• Study Start: May 31, 2022
• Primary Completion: August 15, 2022
• Study Completion: December 16, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)