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

Primary Purpose

Physical Activity, Resistance Exercise, Inflammation

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Resistance exercise training plus hypocaloric diet
Hypocaloric diet
Sponsored by
Elisa Barron-Cabrera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Activity focused on measuring Resistance training, inflammasome, Obesity

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Autonomous University of SinaloaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resistance exercise training plus hypocaloric diet

Hypocaloric diet

Arm 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.

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.

Outcomes

Primary Outcome Measures

NLRP3 gene expression
Assay expression will be performed by real-time PCR using Taqman probes with the 2-ΔΔcq relative quantification method
IL-18 gene expression
Assay expression will be performed by real-time PCR using Taqman probes with the 2-ΔΔcq relative quantification method
IL-18 cytokine
commercial ELISA kit
IL-1b cytokine
commercial ELISA kit

Secondary Outcome Measures

Weight
Weighing machine using bioimpedance technology
Body fat mass
Weighing machine using bioimpedance technology
Serum triglycerides
Liquid chemistry using spectrum equipment
Serum cholesterol
Liquid chemistry using spectrum equipment
Serum glucose
Liquid chemistry using spectrum equipment

Full Information

First Posted
July 27, 2022
Last Updated
July 28, 2022
Sponsor
Elisa Barron-Cabrera
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1. Study Identification

Unique Protocol Identification Number
NCT05482178
Brief Title
The Association of Resistance Exercise With the Inflammasome Activation in Obesity Subjects
Official Title
The Potential Role of Resistance Exercise on Inflammasome Activation and Cytokines Levels in Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
December 16, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elisa Barron-Cabrera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Resistance Exercise, Inflammation, Obesity
Keywords
Resistance training, inflammasome, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance exercise training plus hypocaloric diet
Arm Type
Experimental
Arm 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.
Arm Title
Hypocaloric diet
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Resistance exercise training plus hypocaloric diet
Intervention Description
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
Intervention Name(s)
Hypocaloric diet
Intervention Description
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).
Primary Outcome Measure Information:
Title
NLRP3 gene expression
Description
Assay expression will be performed by real-time PCR using Taqman probes with the 2-ΔΔcq relative quantification method
Time Frame
Change from baseline NLRP3 gene expression at 3 months
Title
IL-18 gene expression
Description
Assay expression will be performed by real-time PCR using Taqman probes with the 2-ΔΔcq relative quantification method
Time Frame
Change from baseline IL-18 gene expression at 3 months
Title
IL-18 cytokine
Description
commercial ELISA kit
Time Frame
Change from baseline IL-18 cytokine at 3 months
Title
IL-1b cytokine
Description
commercial ELISA kit
Time Frame
Change from baseline IL-1b cytokine at 3 months
Secondary Outcome Measure Information:
Title
Weight
Description
Weighing machine using bioimpedance technology
Time Frame
Change from baseline weight at 3 months
Title
Body fat mass
Description
Weighing machine using bioimpedance technology
Time Frame
Change from baseline body fat mass at 3 months
Title
Serum triglycerides
Description
Liquid chemistry using spectrum equipment
Time Frame
Change from baseline serum triglycerides at 3 months
Title
Serum cholesterol
Description
Liquid chemistry using spectrum equipment
Time Frame
Change from baseline serum cholesterol at 3 months
Title
Serum glucose
Description
Liquid chemistry using spectrum equipment
Time Frame
Change from baseline serum glucose at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Vega, PhD
Phone
+526677545353
Email
melissa.vega@uas.edu.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Marcela Vergara, PhD
Phone
+526677545353
Email
mjvergara@uas.edu.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisa Barron, PhD
Organizational Affiliation
Autonomous University of Sinaloa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Autonomous University of Sinaloa
City
Culiacán
State/Province
Sinaloa
ZIP/Postal Code
80019
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Barron, PhD
Phone
+526677556059
Email
elisabarron@uas.edu.mx

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
32249021
Citation
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.
Results Reference
background
PubMed Identifier
26040339
Citation
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.
Results Reference
background
PubMed Identifier
25653548
Citation
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.
Results Reference
background
PubMed Identifier
15070939
Citation
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. Erratum In: J Clin Endocrinol Metab.2004 Jun;89(6):2972.
Results Reference
background
PubMed Identifier
32854610
Citation
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.
Results Reference
result
PubMed Identifier
29683921
Citation
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.
Results Reference
result
PubMed Identifier
20200803
Citation
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.
Results Reference
result

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

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