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

Universitas Sriwijaya

Status and phase: Completed; Phase 3; Phase 2

Conditions: Geriatric; Physical Performance; Muscle Strength; Muscle Mass; Sarcopenia

Treatments: Drug: Placebo; Drug: Ophiochepalus striatus extract

Study type: Interventional

Funder types: Other

Identifiers

NCT05869383

D.XVIII.6.11/ETIK/36/2023

Details and patient eligibility

About

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:

1. Can giving Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase IGF-1 levels in elderly people with sarcopenia?
2. Can administration of 2x5 grams dose of Ophiocephalus striatus extract for 2 weeks reduce IL-6 levels in elderly with sarcopenia?
3. 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?
4. Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle mass in elderly people with sarcopenia?
5. Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle strength in elderly people with sarcopenia?
6. Can administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks improve physical performance in elderly with sarcopenia?

Participants will:

1. Consume Ophiochepalus striatus extract 2x5 grams a day.
2. Checked blood before and after the intervention.
3. Measured muscle mass, muscle strength, and physical performance before and after the intervention.

Enrollment: 80 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Control group get placebo 2x5 grams a day for 14 days

Treatment:

Drug: Placebo

Ophiochepalus striatus extract

Experimental group

Description:

Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days

Treatment:

Drug: Ophiochepalus striatus extract