Clinical trial NCT03065595: The Effect of Ophiocephalus Striatus Extract on Levels of IGF-1, Albumin, and MNA Score in Elderly With Malnutrition
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Keywords: Ophiocephalus striatus
IGF-1
hypoalbuminemia
MNA score
elderly
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum IGF-1
timeFrame: 2 weeks
measure: Serum albumin
timeFrame: 2 weeks
measure: MNA score
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: