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

Primary Purpose

Sarcopenia, Geriatric, Muscle Mass

Status
Recruiting
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Ophiochepalus striatus extract
Placebo
Sponsored by
Universitas Sriwijaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mohammad Hoesin Central General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

IGF-1 Levels
IGF-1 serum Levels
IL-6 levels
IL-6 serum levels

Secondary Outcome Measures

SARC-F Score
SARC-F Score
Muscle Mass
As Appendicular Skeletal Muscle Index
Muscle Strength
measured with handgrip strength
Physical performance
Measured with Time Up and Go test

Full Information

First Posted
May 11, 2023
Last Updated
May 11, 2023
Sponsor
Universitas Sriwijaya
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1. Study Identification

Unique Protocol Identification Number
NCT05869383
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sriwijaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: Can giving Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase IGF-1 levels in elderly people with sarcopenia? Can administration of 2x5 grams dose of Ophiocephalus striatus extract for 2 weeks reduce IL-6 levels in elderly with sarcopenia? 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? Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle mass in elderly people with sarcopenia? Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle strength in elderly people with sarcopenia? Can administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks improve physical performance in elderly with sarcopenia? Participants will: Consume Ophiochepalus striatus extract 2x5 grams a day. Checked blood before and after the intervention. Measured muscle mass, muscle strength, and physical performance before and after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Geriatric, Muscle Mass, Muscle Strength, Physical Performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Control group get placebo 2x5 grams a day for 14 days
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days
Intervention Type
Drug
Intervention Name(s)
Ophiochepalus striatus extract
Other Intervention Name(s)
VipAlbumin
Intervention Description
Ophiochepalus striatus extract 2x5 grams
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo contain maltodextrin
Intervention Description
Placebo 2x5 grams
Primary Outcome Measure Information:
Title
IGF-1 Levels
Description
IGF-1 serum Levels
Time Frame
2 weeks
Title
IL-6 levels
Description
IL-6 serum levels
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
SARC-F Score
Description
SARC-F Score
Time Frame
2 weeks
Title
Muscle Mass
Description
As Appendicular Skeletal Muscle Index
Time Frame
2 weeks
Title
Muscle Strength
Description
measured with handgrip strength
Time Frame
2 weeks
Title
Physical performance
Description
Measured with Time Up and Go test
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nur Riviati
Organizational Affiliation
Mohammad Hoesin General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohammad Hoesin Central General Hospital
City
Palembang
State/Province
South Sumatera
ZIP/Postal Code
30126
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nur Riviati, M.D.
Phone
+6285267026854
Email
eviqodir@yahoo.com
First Name & Middle Initial & Last Name & Degree
Nur Riviati, M.D.
First Name & Middle Initial & Last Name & Degree
Legiran Legiran, M.D.
First Name & Middle Initial & Last Name & Degree
Taufik Indrajaya, M.D.
First Name & Middle Initial & Last Name & Degree
Irsan Saleh, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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