Malnutrition
Conditions
Keywords
Ophiocephalus striatus, IGF-1, hypoalbuminemia, MNA score, elderly
Brief summary
This study is a double-blind randomized controlled trial comparing the effect of Ophiocephalus striatus extract in elderly patients with malnutrition. The measured outcomes are the level of IGF-1, albumin, and MNA score.
Detailed description
This research was conducted in Cipto Mangunkusumo General Hospital and M. Djamil General Hospital, in collaboration with Biomedical Laboratory Faculty of Medicine University of Andalas and Prodia Laboratory, Indonesia. The inclusion criteria were elderly patients (≥ 60 y.o.) with malnutrition (MNA score ≤ 23,5) and hypoalbuminaemia (\< 3,5 g/dL), had been treated, and permitted to leave from the hospital. All participants had been interviewed and physically examined to measure the anthropometric profile. Investigators also measured participant's Activity of Daily Living ADL Barthel, Geriatric Depression Scale (GDS), and Abbreviated Mental Test (AMT) to assess participant's compliance for consuming Ophiocephalus striatus extract. Blood samples were obtained to measure participant's level of IGF-1 and albumin before intervention. Recruited-randomized participants were classified into two groups (control and intervention) with double-blind scheme. Intervention group was given the extract 5 grams two times/day for two weeks. After two weeks, all participants were invited back to out-patient clinic in hospital. MNA score was measured after the intervention. Blood sample were obtained again to know if there were any changes in IGF-1 level and albumin level. Finally, investigators analyzed results to generate the conclusion.
Interventions
DIETARY_SUPPLEMENTOphiochepalus striatus extract
each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day
OTHERPlacebo
each sachet of placebo drug is poured into 50 mL normal water and drink two times/day
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Double-blind, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elderly patient (≥ 60 y.o.) * Malnutrition or high risk for malnutrition (MNA score ≤ 23,5) * Hypoalbunemia (albumin level \< 3,5 g/dL)
Exclusion criteria
* chronic liver disease (liver cirrhosis) or severe liver dysfunction or increasing ALT \> 3x normal * renal dysfunction with glomerulus filtration rate (\< 30mL/minute) * nephrotic syndrome * acute infection / stroke / trauma * neoplasma * depression with Geriatric Depression Scale \> 10 * hypersensitivity to Ophiocephalus striatus * receive parenteral albumin * refuse to accept the treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum IGF-1 | 2 weeks | IGF-1 will be measured from blood serum. The level will be compared between intervention and control group (ng/mL) |
| Serum albumin | 2 weeks | Albumin will be measured from blood serum. The level will be compared between intervention and control group (g/dL) |
| MNA score | 2 weeks | MNA score was measured from direct anamnesis to the patient (or family) and anthropometric profile. |
Outcome results
None listed