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Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

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

NCTNCT05869383 (opens ClinicalTrials.gov in a new tab)Other idD.XVIII.6.11/ETIK/36/2023
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures IGF-1 (mecasermin), does not give it. It appears in an outcome measure.

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
80 participants (actual)
Sponsor
Universitas Sriwijaya · Other
Design
Randomized · Double masking
Countries
1 country

Indonesia

Start
1 May 2023
Primary completion
30 Sept 2023
Completion
30 Oct 2023
First posted
22 May 2023
Last update posted
31 Jan 2025
Conditions
Sarcopenia · Geriatric · Muscle Mass · Muscle Strength · Physical Performance

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20232024
  1. Ph 2/3

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

    NCT05869383

    1 May 2023 to 30 Oct 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Ophiochepalus striatus extractDrug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Placebo

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

  • Experimental

    Ophiochepalus striatus extract

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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. IGF-1 Levels

    Time frame · 2 weeks

    Registry description

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

  2. IL-6 Levels

    Time frame · 2 weeks

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 2 weeks

IGF-1 Levels

GroupValue (ng/dl)Spread
Placebo78.9221.7
Ophiochepalus Striatus Extract77.0820.9
Primary outcomeMean· 2 weeks

IL-6 Levels

GroupValue (pg/dl)Spread
Placebo36.4717.45
Ophiochepalus Striatus Extract44.5123.57

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboControl group get placebo 2x5 grams a day for 14 days Placebo: Placebo 2x5 grams0 / 380 / 386 / 38
Ophiochepalus Striatus ExtractIntervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days Ophiochepalus striatus extract: Ophiochepalus striatus extract 2x5 grams0 / 400 / 408 / 40

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedRiviati 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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