| 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
|
|
|
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
|
|
|
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. Â |
|
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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. |