Geriatric, Muscle Mass, Muscle Strength, Physical Performance, Sarcopenia
Conditions
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. 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 extract 2x5 grams
DRUGPlacebo
Placebo 2x5 grams
Sponsors
Universitas Sriwijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both participant and investigator dont know the intervention that have been given.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IGF-1 Levels | 2 weeks | IGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3. |
| IL-6 Levels | 2 weeks | IL-6 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 41148D2B69. |
Countries
Indonesia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Control group get placebo 2x5 grams a day for 14 days
Placebo: Placebo 2x5 grams | 38 |
| Ophiochepalus Striatus Extract Intervention group get Ophiochepalus striatus extract 2x5 grams a day for 14 days
Ophiochepalus striatus extract: Ophiochepalus striatus extract 2x5 grams | 40 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Ophiochepalus Striatus Extract | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 58 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 20 Participants | 11 Participants |
| Age, Continuous | 70 years | 71 years | 71 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 40 Participants | 78 Participants | 38 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Indonesia | 40 participants | 78 participants | 38 participants |
| Sex: Female, Male Female | 25 Participants | 47 Participants | 22 Participants |
| Sex: Female, Male Male | 15 Participants | 31 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 40 |
| other Total, other adverse events | 6 / 38 | 8 / 40 |
| serious Total, serious adverse events | 0 / 38 | 0 / 40 |
Outcome results
Primary
IGF-1 Levels
IGF-1 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 6854322BA3.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | IGF-1 Levels | 78.92 ng/dl | Standard Deviation 21.7 |
| Ophiochepalus Striatus Extract | IGF-1 Levels | 77.08 ng/dl | Standard Deviation 20.9 |
Primary
IL-6 Levels
IL-6 serum levels were measured using Cloud-Clone Corp® ELISA reagent with serial numbers 41148D2B69.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | IL-6 Levels | 36.47 pg/dl | Standard Deviation 17.45 |
| Ophiochepalus Striatus Extract | IL-6 Levels | 44.51 pg/dl | Standard Deviation 23.57 |