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

NCT05869383 | Completed Phase 2 Results

• 1 other identifier: D.XVIII.6.11/ETIK/36/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 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. 2.Can administration of 2x5 grams dose of Ophiocephalus striatus extract for 2 weeks reduce IL-6 levels in elderly with sarcopenia?
3. 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. 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. 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. 6.Can administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks improve physical performance in elderly with sarcopenia?
7. 7.Consume Ophiochepalus striatus extract 2x5 grams a day.
8. 8.Checked blood before and after the intervention.
9. 9.Measured muscle mass, muscle strength, and physical performance before and after the intervention.

Conditions

Sarcopenia; Geriatric; Muscle Mass; Muscle Strength; Physical Performance

Outcome Measures

Primary Outcomes (2)

• IGF-1 Levels

  IGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3.

  2 weeks

• IL-6 Levels

  IL-6 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 41148D2B69.

  2 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Control group get placebo 2x5 grams a day for 14 days

Drug: Placebo

Ophiochepalus striatus extract

EXPERIMENTAL

Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days

Drug: Ophiochepalus striatus extract

Interventions

Ophiochepalus striatus extract DRUG

Ophiochepalus striatus extract 2x5 grams

Also known as: VipAlbumin

Ophiochepalus striatus extract

Placebo DRUG

Placebo 2x5 grams

Also known as: Placebo contain maltodextrin

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Sriwijaya: lead

Study Sites (1)

Mohammad Hoesin Central General Hospital

Palembang, South Sumatera, 30126, Indonesia

Location

Related Publications (1)

• Riviati N, Legiran L, Saleh I, Indrajaya T, Ali Z, Irfannuddin, Probosuseno. Ophiocephalus striatus Extract Supplementation Decreases Serum IL-6 Levels in Older People with Sarcopenia-A Single-Center Experience. Geriatrics (Basel). 2024 Mar 7;9(2):35. doi: 10.3390/geriatrics9020035.

  PMID: 38525752 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Nur Riviati
• Organization: Sriwijaya University

eviqodir@yahoo.com

+6281377671384

Study Officials

• Nur Riviati

  Mohammad Hoesin General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participant and investigator dont know the intervention that have been given.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Geriatric Division RSUP Dr. Mohammad Hoesin Palembang, Principal Investigator

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: May 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 30, 2023
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)