Clinical trial NCT04315376: Exercise and Diet Intervention Attenuated Inflammation Through ASC Gene and Inflammatory Markers in Obese Adults
Official title: Exercise Program and Diet Intervention Attenuated Inflammation Through Down-regulation of ASC Gene and Inflammatory Markers in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Response
Obesity
Abdominal Obesity
Diet Habit
Exercise
Keywords: Nutrition
Exercise
Diet
Inflammation
Obesity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 37
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A randomized clinical trial was conducted in the Institute of Translational Nutrigenetics and Nutrigenomics, Department of Molecular Biology in Medicine, Health Sciences Center, at the University of Guadalajara, Guadalajara, Jalisco, Mexico, from February of 2018 to February of 2019. All participants were recruited through flyers and social media invitations. Sample size was determined according to the mean difference formula for clinical trials. To achieve a statistical power of 80% and an alpha of 5%, a sample size of 13 participants in each study group was required. However, 37 obese individuals who met the selection criteria were randomized in exercise-diet group or diet-group. Blood sample, height and weight were measured after 8-12 hour fast and wearing light clothes. The participants in the exercise-diet group were cited in the Respiratory Unit of the University of Guadalajara with the indication of not consuming caffeine, tobacco or energy drinks 24 hours before the test, and not having eaten food at least two hours before the Astrand-rhyming Test. This study was approved by the Ethics and Biosafety Committee of the Health Sciences Center, University of Guadalajara (registry number CUCS/CINV/0476/18). The procedures were in accordance with this institution's guidelines and all the participants signed a written consent-informed.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in ASC mRNA Expression
timeFrame: Mean change from baseline (0 Month) to end of treatment at 4th Month.
measure: Change in Pro-inflammatory and Anti-inflammatory Cytokines
timeFrame: Mean change from baseline (0 Month) to end of treatment at 4th Month.
measure: Change in Astrand-rhyming Submaximal Test
timeFrame: Mean change from baseline (0 Month) to end of treatment at 4th Month.
Secondary outcomes:
measure: Changes in Height
timeFrame: 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.
measure: Changes in Weight
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
measure: Changes in Body Mass Index (BMI)
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
measure: Changes in Waist Circumference
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
measure: Changes in Fat Mass
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
measure: Changes in Musculoskeletal Mass
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
measure: Changes in Serum Glucose
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
measure: Changes in Serum Insulin
timeFrame: At the baseline (0 Month), 3th month and the 4th month.
measure: Changes in homeostatic model assessment - insulin resistance (HOMA-IR)
timeFrame: At the baseline (0 Month), 3th month and the 4th month.
measure: Changes in Total Cholesterol
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
measure: Changes in High-density lipoprotein (c-HDL)
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
measure: Changes in Atherogenic Index
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Erika Martínez-López
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Erika Martínez-López, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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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.
citation: 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.
citation: 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.
citation: 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.
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.