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

U

University of Guadalajara

Status

Completed

Conditions

Abdominal Obesity
Diet Habit
Inflammatory Response
Obesity
Exercise

Treatments

Behavioral: Diet Intervention
Behavioral: Exercise-Diet Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04315376
CI-08518

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

25 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

37 participants in 2 patient groups

Exercise-Diet Group
Experimental group
Description:
The participants receive a personal exercise program according to Astrand-rhyming test baseline results, and a hypo-caloric diet intervention
Treatment:
Behavioral: Exercise-Diet Intervention
Diet Group
Active Comparator group
Description:
The participants no receive a personal exercise program, only the hypo-caloric diet
Treatment:
Behavioral: Diet Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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