Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia
Phase: PHASE2
Conditions: Sarcopenia, Geriatric, Muscle Mass, Muscle Strength, Physical Performance
Sponsor: Universitas Sriwijaya

COVER PAGE 
 
 
Study Protocol 
The Effect of Ophiocephalus striatus Extract on IGF-1 and IL-6 
Levels in Elderly Patients with Sarcopenia 
 
Trial Registration Number: NCT05869383 
Date of document: 15 March 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study Objective: To investigate the effects of Ophiocephalus striatus extract on insulin-like 
growth factor-1 serum, interleukin-6 serum levels, and sarcopenia-related parameters in older 
adults with sarcopenia.    
 
Study Design: 
• 
Double-blind, randomized controlled trial.    
• 
80 older adults with sarcopenia.    
• 
Intervention: Ophiocephalus striatus extract or placebo for two weeks.    
• 
Primary outcomes: IGF-1 serum and IL-6 serum levels.    
 
Study Methods: 
• 
Participants:  
o Inclusion criteria: Older adults (≥60 years old) with sarcopenia diagnosed using 
AWGS criteria. 
o Exclusion criteria: Patients with severe chronic liver disease, impaired kidney 
function, 
acute 
disease 
phase, 
malignancy, 
depression, 
history 
of 
hypersensitivity to Ophiocephalus striatus, or those who refused to participate. 
  
• 
Intervention:  
o Ophiocephalus striatus extract (5 g twice daily) or placebo for 2 weeks.    
o Both groups received a tailored diet.    
 
• 
Data Collection:  
o Sociodemographic 
information, 
comorbidities, 
physical 
examinations, 
anthropometric measurements, nutrition assessment, functional status 
assessment, mental status assessment, cognitive status assessment, sarcopenia 
screening, handgrip strength assessment, 6 m walk speed assessment, muscle 
mass 
assessment, 
laboratory 
tests 
for 
IGF-1 
and 
IL-6. 
 
• 
Outcome Measures:  
o Primary outcomes: IGF-1 and IL-6 serum levels.    
o Secondary outcomes: Calf circumference, appendicular skeletal muscle mass 
index (ASMI), handgrip strength, gait speed, creatinine levels.    
 
• 
Data Processing and Analysis:  
o Descriptive and inferential statistics.    
o Paired t-tests, independent t-tests, Wilcoxon test, Mann-Whitney U tests.    
o p-value < 0.05 considered statistically significant.    
Study Results: 
• 
Significant reduction in serum IL-6 levels in the intervention group.    
• 
Non-significant increase in IGF-1 levels in the intervention group.    

• 
Improvements observed in calf circumference, ASMI, handgrip strength, and gait speed 
in the intervention group.    
 
Study Conclusions: 
• 
Ophiocephalus striatus extract positively impacts serum IL-6 levels in older adults with 
sarcopenia.    
• 
The study suggests that Ophiocephalus striatus extract may offer a valuable intervention 
for managing sarcopenia.    
 
Additional Notes: 
• 
The study was conducted at the Geriatric Clinic of RSUP Dr. Mohammad Hoesin, 
Palembang.    
• 
Ethical clearance was obtained from the Research Ethics Commission (No. 
DP.04.03/D.XVIII.6.11/EΤΙΚ/36/2023).    
• 
The study was conducted from March 2023 to August 2023.