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

NCT ID: NCT03065595

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-05
• Study Completion Date: 2017-02-14

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.

Conditions

Malnutrition

Keywords

Ophiocephalus striatus; IGF-1; hypoalbuminemia; MNA score; elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention

Ophicephalus striatus extract

Group Type: PLACEBO_COMPARATOR

Ophiochepalus striatus extract

Intervention Type: DIETARY_SUPPLEMENT

each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day

Control

Placebo drug

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: OTHER

each sachet of placebo drug is poured into 50 mL normal water and drink two times/day

Interventions

Ophiochepalus striatus extract

each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day

Intervention Type: DIETARY_SUPPLEMENT

Placebo

each sachet of placebo drug is poured into 50 mL normal water and drink two times/day

Intervention Type: OTHER

Other Intervention Names

VIP ALBUMIN

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Roza Mulyana

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

16268

Identifier Type: -

Identifier Source: org_study_id