INDIEX
Exercise Program and Diet Intervention Attenuated Inflammation Through Down-regulation of ASC Gene and Inflammatory Markers in Obese Adults
Sponsor study identifier
interventional
37
1 country
1
Study Start
February 10, 2018
Actual (reported)Primary Completion
February 15, 2019
Actual (reported)Study Completion
February 15, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2019
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 10, 2018
Actual (reported)February 15, 2019
Actual (reported)February 15, 2019
Actual (reported)March 15, 2020
Actual (reported)March 19, 2020
Actual (reported)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.
The participants receive a personal exercise program according to Astrand-rhyming test baseline results, and a hypo-caloric diet intervention
The participants no receive a personal exercise program, only the hypo-caloric diet
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.
Erika Martínez-López
Guadalajara, Jalisco, 44340, Mexico
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.
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.
Erika Martínez-López, PhD
University of Guadalajara
37 participants (actual enrollment reported by the registry).
First Submitted
March 15, 2020
First Posted
March 19, 2020
Study Start
February 10, 2018
Actual (reported)Effect of Momordica Charantia Administration on Anthropometric Indicators in Patients With Obesity
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.
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.
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.
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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.
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.
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.
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.
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.
Primary Completion
February 15, 2019
Actual (reported)Study Completion
February 15, 2019
Actual (reported)Last Updated
March 19, 2020
Record last verified: 2020-03
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