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CTRI Number  CTRI/2024/09/074321 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 12/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Other (Specify) [Oral Protein Supplementation ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of Protein Supplementation on Muscle Loss in Hospitalized Patients Measured Using a New Biomarker 
Scientific Title of Study   The effect of protein supplementation on sarcopenia in hospitalized patients measured using a novel biomarker vimentin  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarmini Varatharajan 
Designation  General Medicine Postgraduate Resident  
Affiliation  Saveetha Institute of Medical and Technical Sciences 
Address  Department of General Medicine-Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48

Chennai
TAMIL NADU
602105
India 
Phone  8939250795  
Fax    
Email  sarminiv@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sarmini Varatharajan 
Designation  General Medicine Postgraduate Resident  
Affiliation  Saveetha Institute of Medical and Technical Sciences 
Address  Department of General Medicine-Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48

Chennai
TAMIL NADU
602105
India 
Phone  8939250795  
Fax    
Email  sarminiv@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Sarmini Varatharajan 
Designation  General Medicine Postgraduate Resident  
Affiliation  Saveetha Institute of Medical and Technical Sciences 
Address  Department of General Medicine-Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48

Chennai
TAMIL NADU
602105
India 
Phone  8939250795  
Fax    
Email  sarminiv@hotmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu, 602105 
 
Primary Sponsor  
Name  Sarmini Varatharajan 
Address  Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105 
Type of Sponsor  Other [Self Financing] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sarmini Varatharajan  Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences  Department of General Medicine-Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, 602105
Chennai
TAMIL NADU 
8939250795

sarminiv@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee (SMCH-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M629||Disorder of muscle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral Protein Supplementation  Fifty patients diagnosed with sarcopenia or at risk of developing sarcopenia will be randomly allocated to receive either oral protein supplementation and standard hospital care or standard hospital care. 
Comparator Agent  Serum Vimentin   Vimentin is an intermediate filament protein commonly expressed in mesenchymal cells, playing a crucial role in maintaining cell integrity and stability. In this study, serum vimentin levels are measured as a novel biomarker using enzyme-linked immunosorbent assay to assess potential changes in sarcopenia. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age: Participants must be aged 40 years or above.
2. Diagnosis: Individuals diagnosed with sarcopenia or deemed at risk of developing sarcopenia based on clinical assessment or screening tools.
3. Admission: Patients admitted to Saveetha Medical College Hospital for any medical condition or reason.
4. Consent: Participants must provide informed consent or have a legal guardian provide consent on their behalf. 
 
ExclusionCriteria 
Details  1. Age: Participants under the age of 40 years.
2. Cognitive Impairment: Patients with significant cognitive impairment that may affect their ability to provide informed consent or participate in study assessments.
3. Severe Organ Dysfunction: Individuals with severe renal impairment, hepatic dysfunction, or other significant organ dysfunction that may confound study outcomes or pose safety concerns.
4. Active Malignancy: Patients with active malignancy undergoing treatment.
5. Inability to Provide Informed Consent: Individuals unable to provide informed consent due to language barriers, communication difficulties, or other reasons.
6. Pregnancy or Lactation: Women who are pregnant or lactating.   
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.   Baseline and 2 weeks follow up 
 
Secondary Outcome  
Outcome  TimePoints 
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.
3. Comparison of the effects of protein supplementation versus standard care on muscle mass, strength, functional status, and serum vimentin levels in the intervention and control groups.
4. Evaluation of the potential utility of vimentin as a biomarker for predicting the progression of sarcopenia and response to protein supplementation. 
Baseline and 2 weeks follow up 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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