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临床试验/NCT06579508
NCT06579508进行中(未招募)不适用

Effects of High-intensity Intermittent Exercise With Recovery Hypoxia and Taurine Supplementation in Women With Obesity on Metabolic and Mitochondrial Parameters

University of Sao Paulo4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
4
主要终点
Anthropometry - Height

研究概览

简要总结

The prevalence of obesity in Brazil is one of the highest in Latin America. As an inflammatory disease, obesity needs to be treated, and one of the best interventions is exercise. This research aims to learn more about the effects of combining high-intensity training, recovery hypoxia, and taurine supplementation. To better understand these effects, the researchers will compare hypoxia and normoxia, as well as taurine and placebo, with all participants training in the same way. The researchers will also investigate mitochondrial respiration and food consumption to connect certain aspects of obesity with overall health.

详细描述

Obesity is characterized by a chronic inflammatory state, often linked with elevated oxidative stress and mitochondrial dysfunction. While physical exercise can trigger inflammatory responses due to muscle damage, it also promotes significant bodily adaptations, particularly in body composition, physical fitness, and skeletal muscle tissue, including enhanced mitochondrial dynamics. Moderate hypoxia, when combined with exercise, further amplifies these benefits by increasing the expression of genes related to mitochondrial biogenesis, GLUT1 expression, and angiogenesis. Previous findings suggest that high-intensity physical activity not only improves cardiorespiratory capacity and alters body composition but also significantly elevates inflammation. Consequently, taurine, a supplement known for its anti-inflammatory properties and ability to reduce oxidative stress, should be considered to mitigate these issues and optimize the benefits of exercise and hypoxia. Based on these premises, it is hypothesized that the combination of taurine supplementation with physical training under recovery hypoxia may reduce the significant rise in pro-inflammatory cytokines, thereby enhancing the potential benefits of exercise and moderate hypoxia.

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
Single (Participant)

盲法说明

Participants will be randomly distributed into 5 groups:

Control; Normoxia + placebo (Nor-P); Normoxia + taurine (Nor-T); Hypoxia + placebo (Hyp-P); Hypoxia + Taurine (Hyp-T). Control group is the only group without training

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 25 - 45 years old;
  • BMI between 30 - 35kg/m²;
  • Not be on a diet;
  • Not be on a physical activity program;
  • Not be menopaused.

排除标准

  • Alcoholics;
  • Use thyroid medication;
  • Carry out nutritional monitoring or in treatment for weight loss;
  • Hypertension;
  • Metabolical syndrome;
  • Have any comorbidity associated to obesity;
  • Drugs use.

研究组 & 干预措施

Control

No Intervention

No intervention, only the evaluations will be done.

Normoxia - Placebo

Placebo Comparator

High-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%).

干预措施: Cycle ergometer (Other)

Normoxia - Taurina

Placebo Comparator

High-intensity interval cycle ergometer train, with inter effort normoxia (FiO2 = 21%).

干预措施: Cycle ergometer (Other)

Hypoxia - Placebo

Placebo Comparator

High-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%).

干预措施: Cycle ergometer (Other)

Hypoxia - Taurina

Experimental

High-intensity interval cycle ergometer train, with inter effort hypoxia (FiO2 = 12%).

干预措施: Cycle ergometer (Other)

结局指标

主要结局

Anthropometry - Height

时间窗: 12 weeks

Dual energy x-ray absorptiometry (DEXA) will be use for: Height measured in meters.

Anthropometry - Weight

时间窗: 12 weeks

Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body weight in kilograms (kg).

Anthropometry - BMI

时间窗: 12 weeks

Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body mass index (BMI = weight measured(kg) / (height (m)²).

Lipid profile - Cholesterol

时间窗: 12 weeks

Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in total cholesterol (mg/dL).

Body composition - Free-fat mass

时间窗: 12 weeks

Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for fat-free mass (grams and %).

Body composition - Fat mass

时间窗: 12 weeks

Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for fat mass (grams and %).

Inflammatory profile - pro inflammatory

时间窗: 12 weeks

Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Pro- inflammatory citokines: IL-6, TNF-α (pg/mL).

Inflammatory profile - anti inflammatory

时间窗: 12 weeks

Changes in serum levels of cytokines will be evaluated with MILLIPLEX® Kit. Ant- inflammatory citokines: IL-10 (pg/mL), Adiponectin (ng/mL).

Aerobic performance - HRAnTh

时间窗: 12 weeks

Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using heart rate (HR).

Aerobic performance - IAnTh

时间窗: 12 weeks

Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using intensity in Watts (W).

Aerobic performance - RPEAnTh

时间窗: 12 weeks

Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using Rate of Perceived Effort (RPE).

Aerobic performance - LacAnTh

时间窗: 12 weeks

Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: Anaerobic threshold (AT) using lactate concentration \[lac-\].

Aerobic performance - VO2

时间窗: 12 weeks

Physical tests performed pre-, after 6 weeks and post- intervention to assess aerobic physical fitness by incremental test in cycle ergometer. The test aim to evaluate: VO2peak in ml.kg-1.min-1.

Food Intake

时间窗: 12 weeks

A food record of three non-consecutive days: two days of the week and one day in the weekend. This evaluation will last 12 weeks. Will be evaluated with Dietwin® software (São Paulo, Brazil): The macronutrients, micronutrients and fiber in quilocalories and percentage (%)

Food quality

时间窗: 12 weeks

The feed will undergo analysis through the NOVA Classification. By NOVA, food will be classified into four groups: Group 1 - Unprocessed or minimally processed foods; Group 2 - Processed culinary ingredients; Group 3 - Processed foods; Group 4 - Ultra-processed foods. For each category, the total calories ingested will be calculated, and later, represented in percentage (%) the participation of each food group in the general diet.

Taurine rates

时间窗: 12 weeks

The participants will supplement 3g of taurina or placebo during 12 weeks. The rate of plasmatic taurine (mmol) will be evaluated during pre and post intervention.

Muscle biopsy - RNA

时间窗: 12 weeks

After biopsy the tissue will be treated for: qPCR analysis.

Muscle biopsy - Protein

时间窗: 12 weeks

After biopsy the tissue will be treated for: Western blotting analysis.

Muscle biopsy - Mitochondria

时间窗: 12 weeks

After biopsy the tissue will be treated for: High-resolution respirometry of muscle fibers analysis.

Body composition - Bone

时间窗: 12 weeks

Dual energy x-ray absorptiometry (DEXA) will be use for: Changes in body composition for bone mineral content (g.cm²).

Lipid profile - Triglycerides

时间窗: 12 weeks

Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in triglycerides (mg/dL).

Lipid profile - HDL/LDL

时间窗: 12 weeks

Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in HDL-cholesterol and LDL-cholesterol (mg/dL).

Lipid profile - Glucose

时间窗: 12 weeks

Quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer: Changes in blood glucose (mg/dL).

次要结局

  • Training measures - TRIMP(12 weeks)
  • Training measures - RPE(12 weeks)
  • Training measures - SP02(12 weeks)
  • Training measures - HR(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ellen Cristini de Freitas

Principal Investigator

University of Sao Paulo

研究点 (4)

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