Clinical trial

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

Name
D.XVIII.6.11/ETIK/36/2023
Description
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.
Trial arms
Trial start
2023-05-01
Estimated PCD
2023-09-30
Trial end
2023-10-30
Status
Completed
Phase
Early phase I
Treatment
Ophiochepalus striatus extract
Ophiochepalus striatus extract 2x5 grams
Arms:
Ophiochepalus striatus extract
Other names:
VipAlbumin
Placebo
Placebo 2x5 grams
Arms:
Placebo
Other names:
Placebo contain maltodextrin
Size
80
Primary endpoint
IGF-1 Levels
2 weeks
IL-6 levels
2 weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Both participant and investigator dont know the intervention that have been given.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}
Updated at
2023-11-02

1 organization

2 products

5 indications

Indication
Sarcopenia
Indication
Geriatric
Indication
Muscle Mass
Indication
Muscle Strength
Product
Placebo