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

NCT ID: NCT05482178

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2022-12-16

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.

Detailed 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.

Conditions

Physical Activity; Resistance Exercise; Inflammation; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resistance exercise training plus hypocaloric diet

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.

Group Type: EXPERIMENTAL

Resistance exercise training plus hypocaloric diet

Intervention Type: 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).

Hypocaloric diet

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.

Group Type: ACTIVE_COMPARATOR

Hypocaloric diet

Intervention Type: 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).

Interventions

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).

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Elisa Barron-Cabrera

OTHER

Sponsor Role: lead

Responsible Party

Elisa Barron-Cabrera

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elisa Barron, PhD

Role: PRINCIPAL_INVESTIGATOR

Autonomous University of Sinaloa

Locations

Autonomous University of Sinaloa

Culiacán, Sinaloa, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Melissa Vega, PhD

Role: CONTACT

melissa.vega@uas.edu.mx

+526677545353

Marcela Vergara, PhD

Role: CONTACT

mjvergara@uas.edu.mx

+526677545353

Facility Contacts

Elisa Barron, PhD

Role: primary

elisabarron@uas.edu.mx

+526677556059

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: RESULT

PMID: 32854610 (View on PubMed)

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 20200803 (View on PubMed)

Other Identifiers

CE-FCNYG-2022-FEB-001

Identifier Type: -

Identifier Source: org_study_id