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

Primary Purpose

Malnutrition

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ophiochepalus striatus extract
Placebo
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Ophiocephalus striatus, IGF-1, hypoalbuminemia, MNA score, elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    Ophicephalus striatus extract

    Placebo drug

    Outcomes

    Primary Outcome Measures

    Serum IGF-1
    IGF-1 will be measured from blood serum. The level will be compared between intervention and control group (ng/mL)
    Serum albumin
    Albumin will be measured from blood serum. The level will be compared between intervention and control group (g/dL)
    MNA score
    MNA score was measured from direct anamnesis to the patient (or family) and anthropometric profile.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 19, 2017
    Last Updated
    February 22, 2017
    Sponsor
    Indonesia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03065595
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 5, 2016 (Actual)
    Primary Completion Date
    December 30, 2016 (Actual)
    Study Completion Date
    February 14, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Indonesia University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnutrition
    Keywords
    Ophiocephalus striatus, IGF-1, hypoalbuminemia, MNA score, elderly

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Double-blind, randomized controlled trial
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Placebo Comparator
    Arm Description
    Ophicephalus striatus extract
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Placebo drug
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ophiochepalus striatus extract
    Other Intervention Name(s)
    VIP ALBUMIN
    Intervention Description
    each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    each sachet of placebo drug is poured into 50 mL normal water and drink two times/day
    Primary Outcome Measure Information:
    Title
    Serum IGF-1
    Description
    IGF-1 will be measured from blood serum. The level will be compared between intervention and control group (ng/mL)
    Time Frame
    2 weeks
    Title
    Serum albumin
    Description
    Albumin will be measured from blood serum. The level will be compared between intervention and control group (g/dL)
    Time Frame
    2 weeks
    Title
    MNA score
    Description
    MNA score was measured from direct anamnesis to the patient (or family) and anthropometric profile.
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings

    Learn more about this trial

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

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