UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051518 |
|---|---|
| Receipt number | R000058762 |
| Scientific Title | A cross-sectional study of the effects of nutritional management on energy metabolism and body composition in patients with long-term tube feeding |
| Date of disclosure of the study information | 2023/07/07 |
| Last modified on | 2024/01/23 17:58:18 |
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Basic information
Public title
A cross-sectional study of the effects of nutritional management on energy metabolism and body composition in patients with long-term tube feeding
Acronym
A cross-sectional study on energy metabolism and nutritional management in patients with tube feeding
Scientific Title
A cross-sectional study of the effects of nutritional management on energy metabolism and body composition in patients with long-term tube feeding
Scientific Title:Acronym
A cross-sectional study on energy metabolism and nutritional management in patients with tube feeding
Region
| Japan |
Condition
Condition
Patients receiving enteral tube feeding
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of nutritional management on resting energy expenditure and body composition in patients with long-term tube feeding.
Basic objectives2
Others
Basic objectives -Others
To explore the effects of nutritional management on resting energy expenditure and body composition in patients with long-term tube feeding.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resting energy expenditure and body composition
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Inpatients on tube feeding via gastrostomy, etc.
2. Persons 65 years of age or older.
3. Persons who have been on tube feeding for more than 6 months.
4. Persons who have been receiving nutritional management for at least 3 months using mainly one type of enteral formula.
Key exclusion criteria
1. Persons undergoing nasogastric tube feeding.
2. Persons with weight change of more than 5% over the past 3 months.
3. Persons who consume more than 10% of their energy intake orally.
4. Persons with fever including infection, severe bedsore, trauma, fracture, burn, or post-operative condition who are under treatment.
5. Persons using a ventilator.
6. Persons using an implantable medical device (cardiac pacemaker).
7. Persons undergoing treatment by dialysis.
8. Persons undergoing treatment for cancer or with a serious history of cancer.
9. Persons participating in other clinical trials.
10. Persons who are judged to be unsuitable as subjects by the study investigator or subinvestigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Maruyama |
Organization
Tanashi Hospital Nursing and Medical Care Clinic
Division name
President
Zip code
188-0002
Address
3-6-1 Midoricho, West-tokyo City, Tokyo, Japan
TEL
042-461-2682
m.maruyama@tanashi-hospital.or.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Morita |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Health Care & Nutritional Science Institute, R&D Division
Zip code
252-8583
Address
1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref, Japan
TEL
046-252-3057
Homepage URL
s-morita@morinagamilk.co.jp
Sponsor or person
Institute
Tanashi Hospital Nursing and Medical Care Clinic
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
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
Japan Conference of Clinical Research
Address
1-13-23 Minami-Ikebukuro, Toshima-Ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@jccr.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
田無病院介護医療院（東京都）/Tanashi Hospital Nursing and Medical Care Clinic (Tokyo)
永生病院（東京都）/Eisei Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 07 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058762
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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