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

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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: Ophiochepalus striatus extract; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Intervention; Ophicephalus striatus extract	Dietary supplement: Ophiochepalus striatus extract; each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day; Other Names: VIP ALBUMIN
Active Comparator: Control; Placebo drug	Other: Placebo; each sachet of placebo drug is poured into 50 mL normal water and drink two times/day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2016
• Primary Completion (Actual): December 30, 2016
• Study Completion (Actual): February 14, 2017

Study Registration Dates

• First Submitted: February 19, 2017
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: elderly; IGF-1; hypoalbuminemia; Ophiocephalus striatus; MNA score
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 16268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No