Clinical trial NCT05869383: Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia
Official title: Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sarcopenia
Geriatric
Muscle Mass
Muscle Strength
Physical Performance
Lead sponsor: Universitas Sriwijaya
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: IGF-1 Levels
timeFrame: 2 weeks
measure: IL-6 Levels
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palembang
country: Indonesia
facility: Mohammad Hoesin Central General Hospital
state: South Sumatera
Study officials:
affiliation: Mohammad Hoesin General Hospital
name: Nur Riviati
role: PRINCIPAL_INVESTIGATOR
References: