Effect of High-intensity Interval Training on Low-grade Systemic Inflammation in Obese Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Serum levels of IL-6 between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.
研究概览
简要总结
Background: Obesity is a multifactorial disease that affects 36% of the Mexican population; it is characterized by the excessive accumulation of adipose tissue in the body, mainly in the abdominal region, conditions that are closely linked to low-grade systemic inflammation (LGSI). Scientific evidence suggests that LGSI can be attenuated by the benefits of regular physical exercise, since such activity has the potential to decrease the concentrations of certain proinflammatory molecules, such as reactive C protein, tumor necrosis factor alpha and interleukin 6. Objective: To analyze the LGSI response when intervening with a high-intensity interval training in young obese adults between 18 to 30 years. Materials and methods: The present study is defined as a simple randomized clinical trial. Participants will be randomized into one of two groups of intervention; 1: High-intensity interval training (HIIT), and the control group with moderate-intensity continuous training (MICT). The interventions will be 3 times a week for 2 months, completing a total of 24 sessions. The HIIT group will carry out the activities at high intensity (85 to 95% maximum heart rate) aerobic type training; density of 1 minute at high interval followed by 2 minutes of low interval with a total time of 15 minutes (plus 5 more minutes of warm-up and 5 of cool-down exercises). While the MICT group will carry out the activities with a moderate intensity (60 to 75% maximum heart rate) aerobic type training reaching a total time of 25 to 45 minutes (considering 5 minutes of warm-up and 5 of cool-down exercises). Physical activity will be monitored using a Polar brand heart rate sensor (model H9). Anthropometric, biochemical, and inflammatory assessments will be monitored at baseline, at 4 weeks (mid-intervention), and at 8 weeks (end of intervention). Biochemical parameters will be determined by dry chemistry (Vitros 350), anthropometry by electrical bioimpedance (Inbody 370), and inflammatory markers by blood count and ProQuantum Immunoassay technology. Infrastructure: Institute of Translational Nutrigenomics and Nutrigenomics, University Center for Health Sciences, University of Guadalajara.
详细描述
Detailed description Hypothesis High-intensity interval training decreases inflammatory markers associated with low-grade chronic systemic inflammation in obese young adults aged 18 to 30 years.
Methods Study design Simple randomized clinical trial. Location of the study. Institute of Translational Nutrigenomics and Nutrigenomics of the Department of Molecular Biology and Genomics of the University Center for Health Sciences and at the Tlajomulco University Center of the University of Guadalajara.
Virtual environment: ZOOM
Sample size:
The sample size was determined according to the mean difference formula for clinical trials from a previous study (Barrón et. al, 2020), with a confidence percentage of 95%, statistical power of 90% and alpha of 5%. The sampling is extended to a potentially larger amount of 20% to avoid the negative impact of the results due to the dropout rate of the study subjects. The sample required for each group results from a minimum of 13 subjects per group. Therefore, an "n" of 16 patients per group will be captured.
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
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young adults, between 18 and 30 years.
- •BMI ≥ 30-39.9 kg/m2
- •How signed the informed consent
- •Additionally, it is necessary that they have computer equipment, electronic tablet, or smart cell phone, as well as access to electricity and the Internet.
排除标准
- •Participants who smoke
- •Presence of any of the following comorbidities: hypothyroidism, type 1 diabetes mellitus, type 2 diabetes mellitus, arterial hypertension, oncological pathology, immunological or rheumatic diseases.
- •Consumption of nitrates and anticalcium drugs during the 4 days prior to the start of the investigation and beta blockers, hypoglycemic drugs 7 days prior to the start of the intervention.
- •Pregnant or breastfeeding
- •Men who consume more than 40 g/day of alcohol or women who consume more than 20 g/day
- •Postural and biomechanical alterations (knee, foot or spine)
- •Previous diagnosis and less than 6 months of COVID 19
- •Previous diagnosis of HIV +
- •Previous diagnosis of periodontal disease
结局指标
主要结局
Serum levels of IL-6 between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.
时间窗: Change from baseline of IL-6 at 4 and 8 weeks
Compare serum levels of IL-6 between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.
次要结局
- Waist circumference between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity between 18 and 30 years.(Change from baseline of waist circumference between a high-intensity interval training vs moderate-intensity continuous training at 4 and 8 weeks)
- Serum levels of ultrasensitive reactive C protein between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.(Change from baseline of ultrasensitive reactive C protein at 4 and 8 weeks)
- Body fat between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity between 18 and 30 years.(Body fat and muscle mass percentage between a high-intensity interval training vs moderate-intensity continuous training at 4 and 8 weeks)
- BMI between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity between 18 and 30 years.(BMI between a high-intensity interval training vs moderate-intensity continuous training at 4 and 8 weeks)
- Serum levels of TNFα between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.(Change from baseline of TNFα at 4 and 8 weeks)
- Waist-hip ratio between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity between 18 and 30 years.(Waist-hip ratio between a high-intensity interval training vs moderate-intensity continuous training at 4 and 8 weeks)
- Muscle mass percentage between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity between 18 and 30 years.(Muscle mass percentage between a high-intensity interval training vs moderate-intensity continuous training at 4 and 8 weeks)
- Serum levels of erythrocyte sedimentation rate between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.(Change from baseline of erythrocyte sedimentation rate at 4 and 8 weeks)
- Serum levels of neutrophil-lymphocyte ratio between a high-intensity interval training vs moderate-intensity continuous training in young adults with obesity.(Change from baseline of neutrophil-lymphocyte ratio at 4 and 8 weeks)
研究者
ERIKA MARTINEZ-LOPEZ
Principal Investigator
University of Guadalajara