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
About this trial
This is an interventional treatment trial for Malnutrition focused on measuring Ophiocephalus striatus, IGF-1, hypoalbuminemia, MNA score, elderly
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
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
NCT ID
NCT03065595
First Posted
February 19, 2017
Last Updated
February 22, 2017
Sponsor
Indonesia University
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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