MalnutritionPhase 4NCT03065595
The Effect of Ophiocephalus Striatus Extract on Levels of IGF-1, Albumin, and MNA Score in Elderly With Malnutrition
A Phase 4 study testing Ophiochepalus striatus extract in people with Malnutrition, run by Universitas Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Ophiochepalus striatus extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2016to 14 Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patient (≥ 60 y.o.)
- Malnutrition or high risk for malnutrition (MNA score ≤ 23,5)
- Hypoalbunemia (albumin level < 3,5 g/dL)
Who cannot join
- 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
Show all 9Show fewer
- hypersensitivity to Ophiocephalus striatus
- receive parenteral albumin
- refuse to accept the treatment
About this study
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
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.
Read the 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
- Being tested
- Ophiochepalus striatus extract, Placebo
- Keywords
- Ophiocephalus striatus, IGF-1, hypoalbuminemia, MNA score, elderly
- Medical subject headings
- Malnutrition, Hypoalbuminemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophiochepalus striatus extractDietary supplement
Also called VIP ALBUMIN
each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day
PlaceboOther
each sachet of placebo drug is poured into 50 mL normal water and drink two times/day
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Placebo comparator | Ophicephalus striatus extract Receives: Dietary Supplement: Ophiochepalus striatus extract |
| Control | Active comparator | Placebo drug Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IGF-1
IGF-1 will be measured from blood serum. The level will be compared between intervention and control group (ng/mL)
Measured: 2 weeks
Serum albumin
Albumin will be measured from blood serum. The level will be compared between intervention and control group (g/dL)
Measured: 2 weeks
MNA score
MNA score was measured from direct anamnesis to the patient (or family) and anthropometric profile.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start5 Oct 2016
- Primary completion30 Dec 2016
- Study completion14 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roza Mulyana, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065595
- Sponsor's protocol ID
- 16268
- Status last verified
- Feb 2017
- First submitted
- 19 Feb 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03065595
- Acronym / sponsor ID
- 16268
- Conditions
- Malnutrition
- Keywords
- Ophiocephalus striatus, IGF-1, hypoalbuminemia, MNA score, elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 5 Oct 2016 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Placebo comparator | Dietary Supplement: Ophiochepalus striatus extractOphicephalus striatus extract |
| Control | Active comparator | Other: PlaceboPlacebo drug |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elderly patient (≥ 60 y.o.)
- Malnutrition or high risk for malnutrition (MNA score ≤ 23,5)
- Hypoalbunemia (albumin level < 3,5 g/dL)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophiochepalus striatus extractAlso: VIP ALBUMINeach sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day | Dietary supplement | Intervention |
| Placeboeach sachet of placebo drug is poured into 50 mL normal water and drink two times/day | Other | Control |
Primary outcome
Serum IGF-1
Time frame: 2 weeks
IGF-1 will be measured from blood serum. The level will be compared between intervention and control group (ng/mL)
Serum albumin
Time frame: 2 weeks
Albumin will be measured from blood serum. The level will be compared between intervention and control group (g/dL)
MNA score
Time frame: 2 weeks
MNA score was measured from direct anamnesis to the patient (or family) and anthropometric profile.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: Yes. The research findings will be disseminated via publication of results, submission of information to public accessible databases, or meetings
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ophiochepalus striatus extract in people with Malnutrition, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IGF-1 (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.