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

Phase 2

Completed

• Conditions: Muscle Strength; Geriatric; Sarcopenia; Muscle Mass; Physical Performance
• Interventions: Drug: Placebo; Drug: Ophiochepalus striatus extract

• Registration Number: NCT05869383
• Lead Sponsor: Universitas Sriwijaya

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-30
• Results First Submitted: 2024-09-21
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-04
• Last Update Submitted: 2025-01-04
• Results First Posted: 2025-01-31
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Control group get placebo 2x5 grams a day for 14 days
Ophiochepalus striatus extract	Ophiochepalus striatus extract	Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days

Primary Outcome Measures

Name	Time	Method
IGF-1 Levels	2 weeks	IGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3.
IL-6 Levels	2 weeks	IL-6 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 41148D2B69.

Trial Locations

Locations (1)

Mohammad Hoesin Central General Hospital; 🇮🇩 Palembang, South Sumatera, Indonesia