The Impact of Physical Exercise Associated or Not With Taurine Supplementation on Intramuscular Fat Infiltration in Older Women With Obesity: A Transcriptomic and Metabolomic Approach
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change from Baseline in Intramuscular Fat Fraction Assessed by Magnetic Resonance Imaging (Dixon Technique)
研究概览
简要总结
This randomized clinical trial aims to investigate the effects of multicomponent concurrent exercise training associated or not with taurine supplementation on intramuscular fat infiltration, physical performance, transcriptomic profile, and metabolomic profile in older women with obesity. Forty women aged 60 to 75 years with obesity will be randomized into four groups: control, exercise, taurine, and exercise plus taurine. The intervention will last 16 weeks. Outcomes include magnetic resonance imaging, body composition, muscle biopsy, blood biomarkers, functional capacity tests, transcriptomic analysis, and metabolomic analysis.
详细描述
Aging and obesity are associated with important physiological, metabolic, and functional alterations, including increased intramuscular fat infiltration, also known as myosteatosis. Intramuscular fat infiltration is associated with reduced muscle quality, impaired physical performance, metabolic dysfunction, insulin resistance, and increased risk of morbidity and mortality in older adults.
Physical exercise is recognized as an important non-pharmacological strategy to improve muscle function and metabolic health. In addition, taurine supplementation has demonstrated anti-inflammatory and metabolic effects that may contribute to the reduction of intramuscular fat accumulation and improvement of skeletal muscle health.
However, the synergistic effects of concurrent exercise training associated with taurine supplementation on intramuscular fat infiltration and molecular mechanisms involved in older women with obesity are still unclear.
Therefore, this randomized clinical trial aims to investigate the effects of physical exercise associated or not with taurine supplementation on intramuscular fat infiltration, physical performance, body composition, transcriptomic profile, and metabolomic profile in older women with obesity.
Forty women aged 60 to 75 years with obesity (Body mass index - BMI between 30 and 40 kg/m²) will be randomized into four groups:
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, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to taurine supplementation allocation. Taurine and placebo capsules will be identical in appearance.
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
- 否
入选标准
- •60 and 75 years of age,
- •Body mass lower than 120 kg,
- •Be sedentary (not having engaged in physical exercise for at least 3 months), and
- •Body Mass Index between 30 and 40 kg/m².
排除标准
- •alcohol consumption,
- •infectious and contagious diseases,
- •chronic kidney diseases,
- •undergoing weight loss treatment, and
- •presenting a score ≤13 on cognitive screening using the Mini-Mental State Examination (MMSE).
结局指标
主要结局
Change from Baseline in Intramuscular Fat Fraction Assessed by Magnetic Resonance Imaging (Dixon Technique)
时间窗: Baseline and 16 weeks
Intramuscular fat fraction assessed by magnetic resonance imaging (MRI) using the Dixon technique, reported as percentage (%) of fat within the muscle tissue. Change is calculated from baseline to Week 16.
Change from baseline in plasma taurine concentration
时间窗: Baseline and 16 weeks
Plasma taurine concentration will be measured before and after the 16-week intervention.
Change from baseline in skeletal muscle transcriptomic profile
时间窗: Baseline and 16 weeks
Skeletal muscle biopsy samples will be analyzed using RNA sequencing to characterize changes in the skeletal muscle transcriptomic profile following the intervention.
Change from baseline in plasma metabolomic profile
时间窗: 16 weeks
Plasma samples will be analyzed using untargeted metabolomic analysis to evaluate changes in the plasma metabolomic profile after 16 weeks of intervention.
次要结局
- Change from baseline in fat-free mass(Baseline and 16 weeks)
- Change from baseline in Timed Up and Go test time(Baseline and 16 weeks)
- Change from baseline in handgrip strength(Baseline and 16 weeks)
- Change from baseline in chair stand test performance(Baseline and 16 weeks)
- Change from baseline in forearm flexion test performance(Baseline and 16 weeks)
- Change from baseline in isokinetic knee extensor peak torque(Baseline and 16 weeks)
- Change from baseline in fat mass(Baseline and 16 weeks)
- Change from baseline in fasting blood glucose concentration(Baseline and 16 weeks)
- Change from baseline in fasting insulin concentration(Baseline and 16 weeks)
- Change from baseline in total cholesterol concentration(Baseline and 16 weeks)
- Change from baseline in high-density lipoprotein cholesterol concentration(Baseline and 16 weeks)
- Change from baseline in low-density lipoprotein cholesterol concentration(Baseline and 16 weeks)
- Change from baseline in triglyceride concentration(Baseline and 16 weeks)
- Change from baseline in resting metabolic rate(Baseline and 16 weeks)
研究者
Ellen Cristini de Freitas
Principal Investigator
University of Sao Paulo