The Effect of Ophiocephalus Striatus Extract on Levels of IGF-1, Albumin, and MNA Score in Elderly With Malnutrition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Ophicephalus Striatus Extract on Levels of Insulin-like Growth Factor-1 (IGF-1), Albumin, and Mini Nutritional Assessment Score in Elderly Patients With Malnutrition: A Double Blind Randomized Controlled Trial

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Ophiochepalus striatus extract
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Intervention<br>Ophicephalus striatus extract | Dietary Supplement: Ophiochepalus striatus extract<br>* each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day<br>* Other names: VIP ALBUMIN;|
| Active Comparator: Control<br>Placebo drug | Other: Placebo<br>* each sachet of placebo drug is poured into 50 mL normal water and drink two times/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ophiocephalus striatus, IGF-1, hypoalbuminemia, MNA score, elderly