UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050629 |
|---|---|
| Receipt number | R000057593 |
| Scientific Title | Energy Intake with Power Rice and Nutritional Status in Long-Term Care Facilities |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/03/21 18:26:56 |
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Basic information
Public title
Energy Intake with Power Rice and Nutritional Status in Long-Term Care Facilities
Acronym
Energy Intake with Power Rice and Nutritional Status in Long-Term Care Facilities
Scientific Title
Energy Intake with Power Rice and Nutritional Status in Long-Term Care Facilities
Scientific Title:Acronym
Energy Intake with Power Rice and Nutritional Status in Long-Term Care Facilities
Region
| Japan |
Condition
Condition
Residents of long-term care facilities
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the use of power rice as a staple meal increases energy intake and improves nutritional status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Energy intake
Key secondary outcomes
Dietary intake rate, Nutrient supply, Risk level of malnutrition, BMI, Weight loss, Alb levels, Pressure ulcers, Diarrhea
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
Provide power rice at three meals a day (two meals on days when breakfast is bread) to the study participants for two months.
*Power Rice: Staple food consisting of 240 g whole rice porridge mixed with 7 g MCT oil + 3 g protein powder (240 kcal, 5 g protein, 8 g fat)
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
Residents with oral intake who were admitted to the study facility from April to May 2023, those who have a medium to high risk level of malnutrition, and have whole porridge or porridge jelly.
Key exclusion criteria
Those who are not suitable for power rice due to their diseases, or those who decline the provision of power rice due to their preference.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Misaki |
| Middle name | |
| Last name | Ishii |
Organization
Care Home Funabashi
Division name
Nutrition department
Zip code
273-0851
Address
899-2 Magome-cho, Funabashi-shi, Chiba
TEL
047-406-6200
funabashi_eiyou@tokuyou.jp
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Ishii |
Organization
Care Home Funabashi
Division name
Nutrition department
Zip code
273-0851
Address
899-2 Magome-cho, Funabashi-shi, Chiba
TEL
047-406-6200
Homepage URL
funabashi_eiyou@tokuyou.jp
Sponsor or person
Institute
Care Home Funabashi
Institute
Department
Personal name
Misaki Ishii
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Heisei Medical & Welfare Group Research Institute Ethics Review Committee
Address
2F A Building Kitasando, 1-3-1 Yoyogi, Shibuya-ku, Tokyo
Tel
03-6712-6401
info.research@hmw.gr.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | 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 | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057593
