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临床试验/NCT05415176
NCT05415176进行中(未招募)不适用

Taurine Supplementation Associated or Not With Exercise: Effect on Browning of White Adipose Tissue in Elderly Women With Sarcopenic Obesity

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Browning of white adipose tissue

研究概览

简要总结

The aging process is followed by metabolic and body composition changes, increasing the risk of obesity and sarcopenia. The coexistence of these conditions acts synergistically on each other and is known as sarcopenic obesity. Beige adipose tissue is a tissue type that emerges from subcutaneous white adipose tissue (WAT), altering its phenotype to resemble the thermogenic functions of brown adipose tissue (BAT) in response to beta-adrenergic stimuli. Some in vitro and animal studies suggest that taurine supplementation and physical exercise are effective interventions in stimulating the aforementioned tissue, promoting what is known as WAT darkening, improving energy metabolism and showing benefits on the maintenance of muscle mass via stimulation of the coactivating protein PGC1α. These investigations are scarce in humans and could help health professionals in the adjuvant treatment of sarcopenic obesity. Therefore, the aim of the present study is to analyze the effects of taurine supplementation associated or not with physical exercise on the darkening of the WAT in sarcopenic obese elderly women.

详细描述

The aging process is followed by metabolic and body composition changes, increasing the risk of obesity and sarcopenia. The coexistence of these conditions acts synergistically on each other and is known as sarcopenic obesity. Beige adipose tissue is a tissue type that emerges from subcutaneous white adipose tissue (WAT), altering its phenotype to resemble the thermogenic functions of brown adipose tissue (BAT) in response to beta-adrenergic stimuli. Some in vitro and animal studies suggest that taurine supplementation and physical exercise are effective interventions in stimulating the aforementioned tissue, promoting what is known as WAT darkening, improving energy metabolism and showing benefits on the maintenance of muscle mass via stimulation of the coactivating protein PGC1α. These investigations are scarce in humans and could help health professionals in the adjuvant treatment of sarcopenic obesity. Therefore, the aim of the present study is to analyze the effects of taurine supplementation associated or not with physical exercise on the darkening of the WAT in sarcopenic obese elderly women. Volunteers with low appendicular lean mass (<15 kg) and body mass index (BMI) between 30 and 40 kg/m² will be recruited. These will be subdivided into 4 groups: control group (Cont), taurine (Tau), exercise (Exe) and exercise and taurine (Exe +Tau) and the duration of the intervention for all groups will be 16 weeks. Data related to anthropometry, body composition, biochemical tests, and food intake will be collected. To evaluate the effects on the darkening, a biopsy of the abdominal subcutaneous white adipose tissue will be performed to analyze protein, lipidomic and genetic parameters of this tissue pre and post intervention. Data will be analyzed by Analysis of Variance (ANOVA) or Kruskal-Wallis test depending on the normality of the data that will be tested by Shapiro-Wilk. A significance level for p <0.05 will be admitted. All analyzes will be performed in SPSS version 20 software.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI between 30 and 40kg/m²;
  • Appendicular lean mass below 15 kg;
  • Dynamometry below the cutoff point adjusted for sex and BMI (less than or equal to 21kg);
  • "Sit and stand" test below the cut-off point adjusted for the age group, considering the number of repetitions in 30 seconds;
  • Present medical certificate to perform physical exercise

排除标准

  • alcoholics
  • diseases that prevents the practice of physical activity
  • medical impediment to the practice of physical exercise throughout the study
  • infectious diseases
  • coronary diseases
  • chronic kidney diseases
  • undergoing nutritional monitoring or weight loss treatment
  • score ≤13 for cognitive screening on the Mini-Mental State Examination (MMSE)

结局指标

主要结局

Browning of white adipose tissue

时间窗: 16 weeks

Changes in the gene and protein expression on the subcutaneous white adipose tissue

次要结局

  • Changes in inflamatory markers(16 weeks)
  • Changes in metabolic parameters - lipid profile(16 weeks)
  • Changes in metabolic parameters - fasting blood glucose(16 weeks)
  • Changes in metabolic parameters - insulin sensitivity(16 weeks)
  • Changes in plasma taurine(16 weeks)
  • Indirect calorimetry assessment(16 weeks)
  • Changes in plasma irisin(16 weeks)
  • Body composition changes(16 weeks)
  • Improvement of physical performance(16 weeks)
  • Changes in subcutaneous white adipose tissue (sWAT) morphology(16 weeks)
  • Changes in Lipidomic profile of sWAT(16 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 (2)

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