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

Phase 4

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Ophiochepalus striatus extract; Other: Placebo

• Registration Number: NCT03065595
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2016-10-05
• Primary Completion: 2016-12-30
• Status Verified: 2017-02
• Study Completion: 2017-02-14
• Study First Submitted: 2017-02-19
• Study First Submitted QC: 2017-02-22
• Last Update Submitted: 2017-02-22
• Study First Posted: 2017-02-28
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Ophiochepalus striatus extract	Ophicephalus striatus extract
Control	Placebo	Placebo drug

Primary Outcome Measures

Name	Time	Method
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)
MNA score	2 weeks	MNA score was measured from direct anamnesis to the patient (or family) and anthropometric profile.
Serum albumin	2 weeks	Albumin will be measured from blood serum. The level will be compared between intervention and control group (g/dL)