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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name