UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053171 |
|---|---|
| Receipt number | R000060660 |
| Scientific Title | Effect of high-protein, low-carbohydrate, pectin-contained enteral nutrition in patients with acute phase of stroke |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2025/05/16 09:28:19 |
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Basic information
Public title
Effect of high-protein, low-carbohydrate, pectin-contained enteral nutrition in patients with acute phase of stroke
Acronym
Effect of high-protein, low-carbohydrate, pectin-contained enteral nutrition in patients with acute phase of stroke
Scientific Title
Effect of high-protein, low-carbohydrate, pectin-contained enteral nutrition in patients with acute phase of stroke
Scientific Title:Acronym
Effect of high-protein, low-carbohydrate, pectin-contained enteral nutrition in patients with acute phase of stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the nutritional effect of HINEX Renute in patients with acute phase of stroke by glucose levels, nutritional indices, and gastrointestinal symptoms
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Items related to glucose (maximum value, minimum value, mean value, circadian variation)
Key secondary outcomes
Bowel movements (stool frequency, stool characteristics, diarrhea frequency), gastrointestinal symptoms (abdominal fullness, vomiting, nausea), nutritional indices (transthyretin, body weight), muscle mass, lean body mass
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Administer HINEX Renute for 6 days by tube feeding
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients admitted to the hospital for stroke, 2.Patients with difficulty in oral intake and are expected to receive tube feeding management for more than 6 days, 3.Patients who have given written and verbal explanations fully regarding the participation in this study, and have obtained consent from their own will
Key exclusion criteria
1.Patients with food allergies or potential allergic reactions to the products used in this study, 2.Patients with difficulty in participating in this study due to the combination of hepatic disorder, renal disorder, heart disease, etc, 3.patients who are pregnant, lactating, or potentially pregnant, 4.patients who are considered inappropriate for the study by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koutarou |
| Middle name | |
| Last name | Morita |
Organization
KUWANA HOSPITAL
Division name
Department of Neurosurgery
Zip code
950-0032
Address
140 Kodoko Higashi-ku, Niigata-shi, Niigata-ken
TEL
025-273-2251
kotarobrain@hotmail.com
Public contact
Name of contact person
| 1st name | Kotarou |
| Middle name | |
| Last name | Morita |
Organization
Kuwana Hospital
Division name
Department of Neurosurgery
Zip code
950-0032
Address
140 Kodoko Higashi-ku, Niigata-shi, Niigata-ken
TEL
025-273-2251
Homepage URL
kotarobrain@hotmail.com
Sponsor or person
Institute
Kuwana Hospital
Institute
Department
Personal name
Kotarou Morita
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kuwana Hospital Ethics Committee
Address
140 Kodoko Higashi-ku, Niigata-shi, Niigata-ken
Tel
025-273-2251
kotarobrain@hotmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
202310-01
Org. issuing International ID_1
Kuwana Hospital Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
桑名病院(新潟県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060660
