StrokePhase 2/3NCT01810263
The Efficacy of Intensive Nutritional Supplement in Patient With Stroke
A Phase 2/3 study testing high protein supplement in people with Stroke and Malnutrition, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Malnutrition
- What is being tested?
- high protein supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Jul 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1 st onset stroke patient
- MRI confirms his/her stroke
- more than 2.5% weight los within 2 weeks
- initial serum albumin < 35 g/l
- BMI < 18.5
- more than MMSE 10
- medically stable
Who cannot join
- recurrent stroke patient
- malabsorption patient
- terminal cancer
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, 463-707
About this study
Official title: The Efficacy of Intensive Nutritional Supplement in Patient With Stroke: a Prospective Randomized Controlled Trial
The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke.
Read the detailed description
Elderly patients, including those who have had a stroke, are more at risk of undernutrition than other groups because of reduced nutritional reserves, prolonged hospital stay and increased demands of repeated ill-health. Stroke may compound these problems because of physical and mental incapacity, problems with perception and communication, and swallowing disorders. The full extent of undernutrition and its independent contribution to stroke outcome is not presently known. It is also not known whether it can be corrected, and whether doing so would improve the outcome. The aim of this study is therefore to describe the efficacy of Intensive Nutritional Supplement in Patient with Stroke.
- Conditions
- Stroke, Malnutrition
- Being tested
- high protein supplement
- Keywords
- stroke, malnutrition, high protein
- Medical subject headings
- Stroke, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high protein supplementDietary supplement
Also called Intensive Nutritional Supplement group
Dietary Supplement: high protein supplement
| Study group | Role | What they receive |
|---|---|---|
| high protein supplement | Experimental | high protein supplement given Receives: Dietary Supplement: high protein supplement |
| Control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Barthel Index (MBI) Score at 6 Months
Scale range: 0-100 (higher values represent a better outcome)
Measured: 6 months
Secondary outcomes (1)
Chemical Laboratory Findings
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startMay 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: The study does not seem to provide benefits to patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Myongji Hospital
- Responsible party
- Principal investigator, Nam-Jong Paik, Seoul National University Bundang Hospital
- Investigators
- Nam-Jong Paik, MD, PhD, Principal investigator, Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810263
- Sponsor's protocol ID
- B-1112-069-007
- Status last verified
- Jul 2015
- First submitted
- 1 Feb 2013
- Last updated
- 2 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gariballa SE, Parker SG, Taub N, Castleden M. Nutritional status of hospitalized acute stroke patients. Br J Nutr. 1998 Jun;79(6):481-7. doi: 10.1079/bjn19980085.
PubMed 9771334Axelsson K, Asplund K, Norberg A, Alafuzoff I. Nutritional status in patients with acute stroke. Acta Med Scand. 1988;224(3):217-24. doi: 10.1111/j.0954-6820.1988.tb19364.x.
PubMed 3239449Sakai K, Niimi M, Momosaki R, Hoshino E, Yoneoka D, Nakayama E, Masuoka K, Maeda T, Takahashi N, Sakata N. Nutritional therapy for reducing disability and improving activities of daily living in people after stroke. Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD014852. doi: 10.1002/14651858.CD014852.pub2.
PubMed 39145517
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intensive Nutritional Supplement in Patient With Stroke: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01810263
- Acronym / sponsor ID
- B-1112-069-007
- Conditions
- Stroke, Malnutrition
- Keywords
- stroke, malnutrition, high protein
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study does not seem to provide benefits to patients.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Myongji Hospital
- Study start
- May 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Posted 2 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective randomized controlled study is to demonstrate the efficacy of Intensive Nutritional Supplement in Patient with Stroke.
Detailed description
Elderly patients, including those who have had a stroke, are more at risk of undernutrition than other groups because of reduced nutritional reserves, prolonged hospital stay and increased demands of repeated ill-health. Stroke may compound these problems because of physical and mental incapacity, problems with perception and communication, and swallowing disorders. The full extent of undernutrition and its independent contribution to stroke outcome is not presently known. It is also not known whether it can be corrected, and whether doing so would improve the outcome. The aim of this study is therefore to describe the efficacy of Intensive Nutritional Supplement in Patient with Stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high protein supplement | Experimental | Dietary Supplement: high protein supplementhigh protein supplement given |
| Control | No intervention | –no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 1 st onset stroke patient
- MRI confirms his/her stroke
- more than 2.5% weight los within 2 weeks
- initial serum albumin < 35 g/l
- BMI < 18.5
Key exclusion criteria (3 listed)
- recurrent stroke patient
- malabsorption patient
- terminal cancer
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 |
|---|---|---|
| high protein supplementAlso: Intensive Nutritional Supplement groupDietary Supplement: high protein supplement | Dietary supplement | high protein supplement |
Primary outcome
Modified Barthel Index (MBI) Score at 6 Months
Time frame: 6 months
Scale range: 0-100 (higher values represent a better outcome)
1 secondary outcome
Chemical Laboratory Findings
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9771334Gariballa SE, Parker SG, Taub N, Castleden M. Nutritional status of hospitalized acute stroke patients. Br J Nutr. 1998 Jun;79(6):481-7. doi: 10.1079/bjn19980085.
- Background: PubMed 3239449Axelsson K, Asplund K, Norberg A, Alafuzoff I. Nutritional status in patients with acute stroke. Acta Med Scand. 1988;224(3):217-24. doi: 10.1111/j.0954-6820.1988.tb19364.x.
- Derived from this study: PubMed 39145517Sakai K, Niimi M, Momosaki R, Hoshino E, Yoneoka D, Nakayama E, Masuoka K, Maeda T, Takahashi N, Sakata N. Nutritional therapy for reducing disability and improving activities of daily living in people after stroke. Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD014852. doi: 10.1002/14651858.CD014852.pub2.
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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.
Nam-Jong Paik, MD, PhD principal investigator
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing high protein supplement in people with Stroke and Malnutrition, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Modified Barthel Index (MBI) Score at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01810263, which also lists 3 linked publications.
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 2 Jul 2015.