The effect of protein supplementation on sarcopenia in hospitalized patients measured using a novel biomarker vimentin
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome of this study is the change in muscle mass, as assessed by DEXA scan and change in serum vimentin levels, as measured by ELISA, from baseline to the two-week follow-up.
研究概览
简要总结
Sarcopenia, a multifaceted syndrome characterized by muscle atrophy, dynapenia, and diminished muscle function, poses a significant health challenge, particularly in aging populations. Recognizing nutrition as a modifiable risk factor, there is growing interest in protein supplementation as a strategy to mitigate sarcopenia’s deleterious effects, especially among the elderly. Current guidelines propose higher protein intake than the recommended dietary allowance, acknowledging the heightened amino acid demand of aged muscles to stimulate protein synthesis optimally.
Vimentin, a type III intermediate filament protein expressed in various mesenchymal cells, is emerging as a potential biomarker for sarcopenia. Vimentin has been implicated in cellular processes such as the maintenance of cytoskeletal integrity, cell adhesion, and signaling. Its dysregulation has been associated with various pathological conditions, including muscle wasting disorders. By assessing its correlation with muscle loss and functional decline, we aim to elucidate its diagnostic utility and prognostic value.
In this context, a randomized controlled trial investigating he effects of oral protein supplementation on sarcopenia in hospitalized patients, using serum vimentin as a novel biomarker to assess outcomes will be conducted at Saveetha Medical College Hospital, involving 50 patients aged 40 and above. Muscle mass, strength, functional status, and serum vimentin levels will be measured at baseline and two weeks later to evaluate the impact of oral protein supplementation. The study aims to establish vimentin as a reliable biomarker for sarcopenia and to provide evidence supporting protein supplementation as an effective intervention for mitigating muscle loss in hospitalized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: Participants must be aged 40 years or above.
- •Diagnosis: Individuals diagnosed with sarcopenia or deemed at risk of developing sarcopenia based on clinical assessment or screening tools.
- •Admission: Patients admitted to Saveetha Medical College Hospital for any medical condition or reason.
- •Consent: Participants must provide informed consent or have a legal guardian provide consent on their behalf.
排除标准
- •Age: Participants under the age of 40 years.
- •Cognitive Impairment: Patients with significant cognitive impairment that may affect their ability to provide informed consent or participate in study assessments.
- •Severe Organ Dysfunction: Individuals with severe renal impairment, hepatic dysfunction, or other significant organ dysfunction that may confound study outcomes or pose safety concerns.
- •Active Malignancy: Patients with active malignancy undergoing treatment.
- •Inability to Provide Informed Consent: Individuals unable to provide informed consent due to language barriers, communication difficulties, or other reasons.
- •Pregnancy or Lactation: Women who are pregnant or lactating.
结局指标
主要结局
The primary outcome of this study is the change in muscle mass, as assessed by DEXA scan and change in serum vimentin levels, as measured by ELISA, from baseline to the two-week follow-up.
时间窗: Baseline and 2 weeks follow up
次要结局
- 1. Changes in muscle strength, evaluated using dynamometry, and functional status, assessed by the Barthel index, from baseline to the two-week follow-up.(2. Correlation between changes in serum vimentin levels and improvements in muscle mass, strength, and functional status.)
研究者
Sarmini Varatharajan
Saveetha Institute of Medical and Technical Sciences