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

E

Elisa Barron-Cabrera

Status

Enrolling

Conditions

Inflammation
Physical Activity
Resistance Exercise
Obesity

Treatments

Behavioral: Hypocaloric diet
Behavioral: Resistance exercise training plus hypocaloric diet

Study type

Interventional

Funder types

Other

Identifiers

NCT05482178
CE-FCNYG-2022-FEB-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

25 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Resistance exercise training plus hypocaloric diet
Experimental group
Description:
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.
Treatment:
Behavioral: Resistance exercise training plus hypocaloric diet
Hypocaloric diet
Active Comparator group
Description:
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.
Treatment:
Behavioral: Hypocaloric diet

Trial contacts and locations

1

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Central trial contact

Marcela Vergara, PhD; Melissa Vega, PhD

Data sourced from clinicaltrials.gov

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