Clinical trial NCT05869383
Conditions: Sarcopenia Geriatric Muscle Mass Muscle Strength Physical Performance
Sponsor: Universitas Sriwijaya
Start date: 2023-05-01; Completion date: 2023-10-30
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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:

Arms: arm 1: Control group get placebo 2x5 grams a day for 14 days arm 2: Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days
Interventions: intervention 1: Ophiochepalus striatus extract intervention 2: Placebo
Intervention descriptions: intervention 1: Ophiochepalus striatus extract 2x5 grams intervention 2: Placebo 2x5 grams

Protocol documents:
Prot_SAP_000.pdf: 
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.    
 

ICF_001.pdf: 
COVER PAGE 
 
 
Inform Consent 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


INFORMED CONSENT FORM IN RESEARCH 
 
Researcher  
dr. Nur Riviari, SpPD, K-Ger 
Information 
provider 
dr. Nur Riviari, SpPD, K-Ger 
Information 
recipient 
 
Date 
 
Type of 
information 
Content of Information 
Mark 
 
Research title 
The Effect of Ophiocephalus striatus 
Extract on IGF-1 and IL-6 Levels in Elderly 
Patients with Sarcopenia 
 
 
Research 
objectives 
To determine the effect of Ophiocephalus 
striatus on IGF-1 and IL-6 levels in elderly 
patients with sarcopenia. 
 
 
Research 
methodology 
Research Focus: This research is a clinical 
trial of a drug. Several aspects to be observed 
in this research include nutritional status 
measured through IGF-1 and IL-6 levels. 
 
Research Procedure:The research will be 
conducted at the Geriatrics and Internal 
Medicine Clinic, RSUP Dr. Mohammad 
Hoesin, Palembang. Interviews, physical 
examinations, and blood tests will be 
conducted 
before 
and 
after 
the 
administration of the tested supplement to 
collect the required data. 
 
The physician will explain the background, 
purpose, and procedures of this clinical trial 
and inquire about the willingness to 
participate. If willing, participants will 
undergo 
subject 
selection 
involving 
interviews, physical examinations, and 
laboratory tests (which may also refer to 
medical records). If the tests do not reveal 
significant liver and/or kidney function 
disorders, participants will be asked to 
consent to participate in this clinical trial. 
They will be given the tested supplement to 
consume for 2 weeks. After 2 weeks, 
participants will be re-interviewed, and 
blood samples will be taken again. 
 


 
Research risks 
Participants may experience mild discomfort 
or pain during blood collection, occasionally 
accompanied by slight bruising, which will 
fade within a few days. Rarely, allergic 
reactions may occur. 
 
 
Research 
benefits 
By participating in this research, participants 
contribute valuable scientific information 
about the effects of Ophiocephalus striatus 
(snakehead 
fish) 
extract, 
particularly 
whether 
it 
can 
improve 
sarcopenia 
conditions in the elderly. 
 
 
Alternative 
procedures 
There are no alternative procedures. 
 
 
 
Confidentiality 
of data 
All 
information 
obtained 
during 
this 
research, including personal and research 
data, will be kept confidential. The 
participant’s name or any documents 
identifying them as part of the research will 
not be disclosed without their consent. 
 
 
Compensation 
in case of side 
effects 
Any 
significant 
incidents, 
such 
as 
hospitalization or death, must be reported to 
the researcher via phone. Participants 
experiencing complaints can contact the 
researcher 24/7 by phone. Participants 
reporting side effects will be asked to come 
for further anamnesis, physical examination, 
and laboratory tests as indicated. 
 
 
Researcher's 
Name 
and 
Address 
Dr. 
Nur 
Riviati, 
SpPD, 
K-Ger 
Jl. DR. Hakim No. 1120, Sei Pangeran, Ilir 
Timur I, Palembang 
 
 
Number 
of 
subjects 
80 
 
 
Potential 
hazards  
Allergic reactions to Ophiocephalus striatus 
extract 
 
 
Cost incurred 
In case of significant side effects 
 
 
 
Incentives 
for 
participants 
Light refreshments  
 
I hereby state that I have explained the above matters truthfully 
and provided an opportunity for questions and/or discussions. 
Researcher’s 
signature 
I hereby state that I have received the information as mentioned 
above, which I have marked/initialed in the respective column, 
and I understand it. 
Participant’s 
signature