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Effects of Protein Supplementation on Muscle Loss in Hospitalized Patients Measured Using a New Biomarker

The effect of protein supplementation on sarcopenia in hospitalized patients measured using a novel biomarker vimentin - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074321
Enrollment
50
Registered
2024-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M629- Disorder of muscle, unspecified

Interventions

Intervention1: 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

Sponsors

Sarmini Varatharajan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Baseline and 2 weeks follow up

Secondary

MeasureTime frame
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.Timepoint: Baseline and 2 weeks follow up

Countries

India

Contacts

Public ContactSarmini Varatharajan

Saveetha Institute of Medical and Technical Sciences

sarminiv@hotmail.com8939250795

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026