Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia

Study Overview
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Brief Summary
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The goal of this Clinical Trial is to analyze effect of Ophiochepalus striatus extract on serum IGF-1 and IL-6 levels in elderly patients with sarcopenia. The main questions it aims to answer are: Can giving Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase IGF-1 levels in elderly people with sarcopenia? Can administration of 2x5 grams dose of Ophiocephalus striatus extract for 2 weeks reduce IL-6 levels in elderly with sarcopenia? Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks reduce the SARC-F score in elderly people with sarcopenia? Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle mass in elderly people with sarcopenia? Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle strength in elderly people with sarcopenia? Can administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks improve physical performance in elderly with sarcopenia? Participants will: Consume Ophiochepalus striatus extract 2x5 grams a day. Checked blood before and after the intervention. Measured muscle mass, muscle strength, and physical performance before and after the intervention.

Official Title
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Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia

Conditions
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Muscle Mass, Muscle Strength, Physical Performance, Sarcopenia, Geriatric

Intervention / Treatment
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* Drug: Ophiochepalus striatus extract
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly patients with sarcopenia diagnosed using AWGS criteria consist of low muscle mass: using the BIA examination tool where men: <7.0kg/m2, women: <5.7kg/m2 plus low muscle strength using a handgrip dynamometer, men: <28kg , female : <18kg or low physical performance using the 6 meter walk test; <1 meter/second. Exclusion Criteria: Chronic liver disease (cirrhosis of the liver) or severe liver dysfunction or increased SGPT> 3 times the upper limit of normal value Impaired kidney function with a glomerular filtration rate <30 ml/minute without hemodialysis Acute phase of illness (eg infection, acute arthritis, acute stroke, trauma) Malignancy Depression according to the geriatric depression scale (Geriatric Depression Scale score> 10) History of hypersensitivity to Ophiocephalus striatus Refuse to participate in research

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Control group get placebo 2x5 grams a day for 14 days | Drug: Placebo<br>* Placebo 2x5 grams<br>* Other names: Placebo contain maltodextrin;|
| Experimental: Ophiochepalus striatus extract<br>Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days | Drug: Ophiochepalus striatus extract<br>* Ophiochepalus striatus extract 2x5 grams<br>* Other names: VipAlbumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-1 Levels | IGF-1 serum Levels | 2 weeks | 
| IL-6 levels | IL-6 serum levels | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARC-F Score | Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls. Min-Max = 0 - 10 | 2 weeks | 
| Muscle Mass | As Appendicular Skeletal Muscle Index | 2 weeks | 
| Muscle Strength | measured with handgrip strength | 2 weeks | 
| Physical performance | Measured with Time Up and Go test | 2 weeks |