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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05869383
• Other study ID #: D.XVIII.6.11/ETIK/36/2023
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 1, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: October 2023
• Source: Universitas Sriwijaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Geriatric
• Muscle Mass
• Muscle Strength
• Physical Performance
• Sarcopenia

Intervention

Drug:
• Ophiochepalus striatus extract
Ophiochepalus striatus extract 2x5 grams
• Placebo
Placebo 2x5 grams

Locations

Country	Name	City	State
Indonesia	Mohammad Hoesin Central General Hospital	Palembang	South Sumatera

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sriwijaya

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGF-1 Levels	IGF-1 serum Levels	2 weeks
Primary	IL-6 levels	IL-6 serum levels	2 weeks
Secondary	SARC-F Score	Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls. Min-Max = 0 - 10	2 weeks
Secondary	Muscle Mass	As Appendicular Skeletal Muscle Index	2 weeks
Secondary	Muscle Strength	measured with handgrip strength	2 weeks
Secondary	Physical performance	Measured with Time Up and Go test	2 weeks