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临床试验/NCT05437952
NCT05437952Unknown不适用

Metabolic and Molecular Responses Under the Effect of Taurine Supplementation With and Without Multicomponent Training in Elderly Women With Sarcopenic Obesity Using the Metabolomics Approach

University of Sao Paulo0 个研究点目标入组 60 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Metabolomic Profile

研究概览

简要总结

Sarcopenic obesity is characterized by a progressive decline in muscle mass and an increase in body fat, a condition especially present in the elderly. A significant improvement in metabolic parameters has been observed with the completion of taurine supplementation and also with the practice of physical exercise, but there are no studies associating the interventions mentioned above with the aim of analyzing the metabolic profile of elderly people with sarcopenic obesity. The metabolomics approach allows the study of a whole set of metabolites involved in a biological system. It is believed that taurine supplementation associated with physical exercise is capable of promoting positive contributions to the metabolic profile, investigated through a metabolomics approach. Therefore, the present study seeks to investigate whether taurine supplementation associated with exercise is able to promote contributions to the metabolic profile, through a metabolomics approach, in elderly women with sarcopenic obesity.

详细描述

Sarcopenic obesity is characterized by a progressive decline in muscle mass and an increase in body fat, a condition especially present in the elderly. A significant improvement in metabolic parameters has been observed with the completion of taurine supplementation and also with the practice of physical exercise, but there are no studies associating the interventions mentioned above with the aim of analyzing the metabolic profile of elderly people with sarcopenic obesity. The metabolomics approach allows the study of a whole set of metabolites involved in a biological system. It is believed that taurine supplementation associated with physical exercise is capable of promoting positive contributions to the metabolic profile, investigated through a metabolomics approach. The study will involve 60 elderly women with sarcopenic obesity who will be randomly distributed into 4 groups: 1) GPL, submitted to placebo supplementation (n=15); 2) GTAU, submitted to taurine supplementation (n=15); 3) GPL+EX, submitted to placebo supplementation associated with physical exercise (n=15) and 4) GTAU+EX, submitted to taurine supplementation associated with physical exercise (n=15). The interventions will take place for 16 weeks, collections and evaluations will be carried out pre and post-intervention of functional capacity testing, anthropometry, resting energy expenditure, biopsy of white adipose tissue for analysis of gene expression and blood collection for analysis of the plasma concentration of taurine and of the metabolomic profile. Body composition, and food consumption will be evaluated pre, during and post-intervention. The synergistic effects of the proposed intervention are expected to improve the metabolic parameters, regarding the profile anti-inflammatory, antioxidant, lipid metabolism, body composition, and functional physical capacity in elderly women with sarcopenic obesity.

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
Double (Participant, Investigator)

盲法说明

The study will involve 60 elderly women with sarcopenic obesity who will be randomly distributed into 4 groups: 1) GPL, submitted to placebo supplementation (n=15); 2) GTAU, submitted to taurine supplementation (n=15); 3) GPL+EX, submitted to placebo supplementation associated with physical exercise (n=15) and 4) GTAU+EX, submitted to taurine supplementation associated with physical exercise (n=15).

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
  • with any disease 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), suggested by Bertolucci et al. (1994).

结局指标

主要结局

Metabolomic Profile

时间窗: 16 weeks

Changes in metabolites and lipids of the biological sample investigated through the metabolomics approach.

次要结局

  • Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of lipid oxidation genes markers.(16 weeks)
  • Functional ability tests: chair sit-up test. (seconds)(16 weeks)
  • Changes in Plasma Taurine Concentration(16 weeks)
  • Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of infammatory gene markers.(16 weeks)
  • Functional ability tests: muscle strength (dynamometer) - highest peak force (KGF)(16 weeks)
  • Others changes in metabolic parameters(16 weeks)
  • Indirect calorimetry assessment(16 weeks)
  • Body composition changes (%)(16 weeks)
  • Gene expressions in the subcutaneous white adipose tissue (scWAT). RNA (mRNA) levels of oxidative stress genes markers.(16 weeks)
  • Functional ability tests: Six-minute walk test (minutes)(16 weeks)
  • Functional ability tests: forearm flexion test (seconds)(16 weeks)
  • Anthropometric measurements (Body weight)(16 weeks)
  • Anthropometric - height assessment (meters)(16 weeks)
  • Anthropometric measurements (Circumferences)(16 weeks)
  • Food Intake changes(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

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