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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Placebo Comparator | Ophicephalus striatus extract |
|
| Control | Active Comparator | Placebo drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ophiochepalus striatus extract | Dietary Supplement | each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum IGF-1 | IGF-1 will be measured from blood serum. The level will be compared between intervention and control group (ng/mL) | 2 weeks |
| Serum albumin | Albumin will be measured from blood serum. The level will be compared between intervention and control group (g/dL) | 2 weeks |
| MNA score | MNA score was measured from direct anamnesis to the patient (or family) and anthropometric profile. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D034141 | Hypoalbuminemia |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D007019 | Hypoproteinemia |
| D001796 | Blood Protein Disorders |
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Double-blind, randomized controlled trial
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|
| Placebo | Other | each sachet of placebo drug is poured into 50 mL normal water and drink two times/day |
|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |