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Completed

NCT Number: NCT05869383

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.

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Key information

Conditions

Sarcopenia Atrophy Geriatric Muscle Mass Muscle Strength Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Physical Performance Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mohammad Hoesin Central General Hospital

Palembang, South Sumatera, 30126, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ophiochepalus striatus extract

Drug

Ophiochepalus striatus extract 2x5 grams

Other names: VipAlbumin

Placebo

Drug

Placebo 2x5 grams

Other names: Placebo contain maltodextrin

Primary outcomes

  1. IGF-1 Levels

    Time frame: 2 weeks

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

  2. IL-6 Levels

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

Universitas Sriwijaya

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 22, 2023
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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