Exercise Program and Diet Intervention Attenuated Inflammation Through Down-regulation of ASC Gene and Inflammatory Markers in Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in ASC mRNA Expression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pregnant or breastfeeding women
- •Diagnosis of any metabolic disease or cancer
- •Alcohol or tobacco consumption
- •Muscle or joint injury
结局指标
主要结局
Change in ASC mRNA Expression
时间窗: Mean change from baseline (0 Month) to end of treatment at 4th Month.
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.
Change in Pro-inflammatory and Anti-inflammatory Cytokines
时间窗: Mean change from baseline (0 Month) to end of treatment at 4th Month.
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.
Change in Astrand-rhyming Submaximal Test
时间窗: Mean change from baseline (0 Month) to end of treatment at 4th Month.
The Astrand-rhyming submaximal test was performed as described by Astrand.
次要结局
- Changes in Weight(At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.)
- Changes in Total Cholesterol(At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.)
- Changes in High-density lipoprotein (c-HDL)(At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.)
- Changes in Atherogenic Index(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 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 Fat Mass(At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.)
- Changes in Musculoskeletal Mass(At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.)
- Changes in Serum Glucose(At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.)
- Changes in Serum Insulin(At the baseline (0 Month), 3th month and the 4th month.)
- Changes in homeostatic model assessment - insulin resistance (HOMA-IR)(At the baseline (0 Month), 3th month and the 4th month.)
研究者
ERIKA MARTINEZ-LOPEZ
Study director
University of Guadalajara