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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Muscle Strength; Geriatric; Physical Performance; Muscle Mass
• Intervention / Treatment: Drug: Placebo; Drug: Ophiochepalus striatus extract

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • South Sumatera
    • Palembang, South Sumatera, Indonesia, 30126
      • Mohammad Hoesin Central General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Control group get placebo 2x5 grams a day for 14 days	Drug: Placebo; Placebo 2x5 grams; Other Names: Placebo contain maltodextrin
Experimental: Ophiochepalus striatus extract; Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days	Drug: Ophiochepalus striatus extract; Ophiochepalus striatus extract 2x5 grams; Other Names: VipAlbumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGF-1 Levels	IGF-1 serum Levels	2 weeks
IL-6 levels	IL-6 serum levels	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Mass	As Appendicular Skeletal Muscle Index	2 weeks
Muscle Strength	measured with handgrip strength	2 weeks
Physical performance	Measured with Time Up and Go test	2 weeks
SARC-F Score	Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls. Min-Max = 0 - 10	2 weeks

Collaborators and Investigators

• Sponsor: Universitas Sriwijaya
• Investigators: Principal Investigator: Nur Riviati, Mohammad Hoesin General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: D.XVIII.6.11/ETIK/36/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No