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

Sponsor
Elisa Barron-Cabrera (Other)
Overall Status
Recruiting
CT.gov ID
NCT05482178
Collaborator
(none)
20
1
2
6.5
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Resistance exercise training plus hypocaloric diet
  • Behavioral: Hypocaloric diet
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
ExperimentalExperimental
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Potential Role of Resistance Exercise on Inflammasome Activation and Cytokines Levels in Obese Subjects
Actual Study Start Date :
May 31, 2022
Anticipated Primary Completion Date :
Aug 15, 2022
Anticipated Study Completion Date :
Dec 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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).

Active Comparator: 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.

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).

Outcome Measures

Primary Outcome Measures

  1. NLRP3 gene expression [Change from baseline NLRP3 gene expression at 3 months]

    Assay expression will be performed by real-time PCR using Taqman probes with the 2-ΔΔcq relative quantification method

  2. IL-18 gene expression [Change from baseline IL-18 gene expression at 3 months]

    Assay expression will be performed by real-time PCR using Taqman probes with the 2-ΔΔcq relative quantification method

  3. IL-18 cytokine [Change from baseline IL-18 cytokine at 3 months]

    commercial ELISA kit

  4. IL-1b cytokine [Change from baseline IL-1b cytokine at 3 months]

    commercial ELISA kit

Secondary Outcome Measures

  1. Weight [Change from baseline weight at 3 months]

    Weighing machine using bioimpedance technology

  2. Body fat mass [Change from baseline body fat mass at 3 months]

    Weighing machine using bioimpedance technology

  3. Serum triglycerides [Change from baseline serum triglycerides at 3 months]

    Liquid chemistry using spectrum equipment

  4. Serum cholesterol [Change from baseline serum cholesterol at 3 months]

    Liquid chemistry using spectrum equipment

  5. Serum glucose [Change from baseline serum glucose at 3 months]

    Liquid chemistry using spectrum equipment

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Autonomous University of Sinaloa Culiacán Sinaloa Mexico 80019

Sponsors and Collaborators

  • Elisa Barron-Cabrera

Investigators

  • Principal Investigator: Elisa Barron, PhD, Autonomous University of Sinaloa

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Elisa Barron-Cabrera, Professor, Universidad Autónoma de Sinaloa
ClinicalTrials.gov Identifier:
NCT05482178
Other Study ID Numbers:
  • CE-FCNYG-2022-FEB-001
First Posted:
Aug 1, 2022
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elisa Barron-Cabrera, Professor, Universidad Autónoma de Sinaloa
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2022