Exercise and Diet Intervention Attenuated Inflammation Through ASC Gene and Inflammatory Markers in Obese Adults

NCT04315376 | Completed DMC

• 1 other identifier: CI-08518
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Obesity is one of the most important health problems worldwide, several factors related to lifestyle as physical inactivity and unbalanced diets increase their development. This condition is characterized by low-chronic inflammation by excess of adipose tissue. The apoptosis-associated speck-like protein containing a caspase recruitment domain (ASC) protein is part of NLRP3 inflammasome, a complex related to inflammation and metabolic alterations. Purpose: The aim of this study was to evaluate the effect of physical exercise program on ASC gene expression and inflammatory markers in obese adults. Methods: 37 obese individuals were randomized to exercise-diet group or diet-group during a 4-month follow-up period. The dietary evaluation was analyzed by Nutritionist Pro software. Body composition was evaluated by bioimpedance (InBody 370). All biochemical determinations were analyzed by dry chemistry (Vitros 350). ASC messenger ribonucleic acid (mRNA) expression was performed by real-time polymerase chain reaction (PCR) using Taqman probes and by the 2-ΔΔcq quantification method. Cytokine levels was performed using the Bio-PlexPro™ HumanTh17Cytokine Assays (MagPix) panel. Statistical analysis was performed with Statistical Package for the Social Sciences (SPSS) v.22 software.

Conditions

Inflammatory Response; Obesity; Abdominal Obesity; Diet Habit; Exercise

Keywords

Nutrition; Exercise; Diet; Inflammation; Obesity

Outcome Measures

Primary Outcomes (3)

• Change in ASC mRNA Expression

  The polymorphonuclear cells were separated using Dextran treatment from peripheral blood samples. Subsequently, TRIzol® reagent was using according to the manufacturer´s instructions. The complementary DNA (cDNA) synthesis was performed according to standard techniques. Quantitative real-time PCR was performed using TaqMan® probes in Light Cycler 96 equipment considering standards PCR conditions to analyze ASC mRNA relative expression by 2-ΔΔcq method. The amplification reactions were performed in duplicate using β-Actin gene as constitutive gene to normalized the samples.

  Mean change from baseline (0 Month) to end of treatment at 4th Month.

• Change in Pro-inflammatory and Anti-inflammatory Cytokines

  The pro-inflammatory and anti-inflammatory cytokines quantification were using Bio-Plex Pro™ Human cytokine Standard 17-Plex, Group I kit following the supplier's instructions, and the read was immediately by MAGPIX™ analyzer.

  Mean change from baseline (0 Month) to end of treatment at 4th Month.

• Change in Astrand-rhyming Submaximal Test

  The Astrand-rhyming submaximal test was performed as described by Astrand.

  Mean change from baseline (0 Month) to end of treatment at 4th Month.

Secondary Outcomes (12)

• Changes in Height

  At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month. 1st month, 2nd month, 3th month and the 4th month.

• Changes in Weight

  At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

• Changes in Body Mass Index (BMI)

  At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

• Changes in Waist Circumference

  At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

• Changes in Fat Mass

  At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

Study Arms (2)

Exercise-Diet Group

EXPERIMENTAL

The participants receive a personal exercise program according to Astrand-rhyming test baseline results, and a hypo-caloric diet intervention

Behavioral: Exercise-Diet Intervention

Diet Group

ACTIVE COMPARATOR

The participants no receive a personal exercise program, only the hypo-caloric diet

Behavioral: Diet Intervention

Interventions

Exercise-Diet Intervention BEHAVIORAL

The participants who performed exercise-diet intervention performed an Astrand-rhyming test before and after the exercise program intervention. Participants followed a progressive exercise-program during four months according to initial physical fitness. The main exercises consisted of improving aerobic, speed and resistance performance. During all single sessions, breathlessness and fatigue were measured using 0 to10 Borg scale. A personal trainer certified by American College of Sports Medicine (ACSM) supervised three sessions per week, the other two unsupervised training days the subjects were given the detailed training program to do in house/park. And also, this group received a diet intervention that consisted of a 20 percentage reduction of total energy expenditure estimated by the Mifflin formula with a nutrients distribution as follows: 50% carbohydrates, 30% lipids, and 20% proteins.

Exercise-Diet Group

Diet Intervention BEHAVIORAL

This group received a diet intervention that consisted of a 20 percentage reduction of total energy expenditure estimated by the Mifflin formula with a nutrients distribution as follows: 50% carbohydrates, 30% lipids, and 20% proteins.

Diet Group

Eligibility Criteria

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

You may qualify if:

• BMI greater than 30 kg/m\^2
• Sedentary individuals
• Both genres
• Waist circumference greater than 80 centimeters in women and greater than 90 centimeters in men

You may not qualify if:

• Pregnant or breastfeeding women
• Diagnosis of any metabolic disease or cancer
• Alcohol or tobacco consumption
• Muscle or joint injury

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Erika Martínez-López

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (7)

• ASTRAND PO, RYHMING I. A nomogram for calculation of aerobic capacity (physical fitness) from pulse rate during sub-maximal work. J Appl Physiol. 1954 Sep;7(2):218-21. doi: 10.1152/jappl.1954.7.2.218. No abstract available.

  PMID: 13211501 RESULT

• Lin CH, Chiang SL, Tzeng WC, Chiang LC. Systematic review of impact of lifestyle-modification programs on metabolic risks and patient-reported outcomes in adults with metabolic syndrome. Worldviews Evid Based Nurs. 2014 Dec;11(6):361-8. doi: 10.1111/wvn.12069.

  PMID: 25488565 RESULT

• 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 RESULT

• Ross R, Hudson R, Stotz PJ, Lam M. Effects of exercise amount and intensity on abdominal obesity and glucose tolerance in obese adults: a randomized trial. Ann Intern Med. 2015 Mar 3;162(5):325-34. doi: 10.7326/M14-1189.

  PMID: 25732273 RESULT

• Taniguchi S, Sagara J. Regulatory molecules involved in inflammasome formation with special reference to a key mediator protein, ASC. Semin Immunopathol. 2007 Sep;29(3):231-8. doi: 10.1007/s00281-007-0082-3. Epub 2007 Sep 6.

  PMID: 17805543 RESULT

• You T, Arsenis NC, Disanzo BL, Lamonte MJ. Effects of exercise training on chronic inflammation in obesity : current evidence and potential mechanisms. Sports Med. 2013 Apr;43(4):243-56. doi: 10.1007/s40279-013-0023-3.

  PMID: 23494259 RESULT

• 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 DERIVED

MeSH Terms

Conditions

Obesity; Obesity, Abdominal; Feeding Behavior; Motor Activity; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Erika Martínez-López, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: March 19, 2020
• Study Start: February 10, 2018
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)