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

NCT03065595 | Completed Phase 4 DMC

• 1 other identifier: 16268
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malnutrition

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention

PLACEBO COMPARATOR

Ophicephalus striatus extract

Dietary Supplement: Ophiochepalus striatus extract

Control

ACTIVE COMPARATOR

Placebo drug

Other: Placebo

Interventions

Ophiochepalus striatus extract DIETARY_SUPPLEMENT

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

Also known as: VIP ALBUMIN

Intervention

Placebo OTHER

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

Control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elderly patient (≥ 60 y.o.)
• Malnutrition or high risk for malnutrition (MNA score ≤ 23,5)
• Hypoalbunemia (albumin level \< 3,5 g/dL)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

MeSH Terms

Conditions

Malnutrition; Hypoalbuminemia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Double-blind, randomized controlled trial

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: February 28, 2017
• Study Start: October 5, 2016
• Primary Completion: December 30, 2016
• Study Completion: February 14, 2017
• Last Updated: February 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share