UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057031 |
|---|---|
| Receipt number | R000065089 |
| Scientific Title | A study to verify the effectiveness of a dairy product in the elderly. |
| Date of disclosure of the study information | 2025/02/17 |
| Last modified on | 2025/03/13 16:24:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to verify the effectiveness of a dairy product in the elderly.
Acronym
A study to verify the effectiveness of a dairy product in the elderly.
Scientific Title
A study to verify the effectiveness of a dairy product in the elderly.
Scientific Title:Acronym
A study to verify the effectiveness of a dairy product in the elderly.
Region
| Japan |
Condition
Condition
Adult male and female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of a fermented milk containing lactic acid bacteria on nutritional status and weight in elderly people for 48 weeks of continuous intake, and to conduct an exploratory evaluation of indicators of health in the elderly, as well as to examine the safety of the product.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight
Key secondary outcomes
BMI, muscle mass, appendicular skeletal muscle mass, appendicular skeletal muscle mass index, grip strength, blood markers such as nutritional indexes, dietary survey, GDS15, CNAQ-J, PSQI-J, daily life record (fever, hospitalization)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of test food (1 bottle a day) for 48 weeks
Interventions/Control_2
No intake
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Male and female aged 75 years or older
(2) Subjects who have been certified as needing assistance level 1, assistance level 2, nursing care level 1, or nursing care level 2
(3) Subjects with a BMI of less than 25 kg/m^2
(4) Subjects who can obtain written consent to participate in the study from the person himself/herself or a legal representative regarding the purpose and content of the study. When obtaining consent from a legal representative, the purpose and content of the study must be explained to the subject so that he/she can understand it, and an effort must be made to obtain consent from the subject himself/herself (informed assent)
Key exclusion criteria
(1) Subjects suffering from a disease that may be life-threatening during the study period
(2) Subjects who have difficulty orally ingesting the study food
(3) Subjects who cannot ingest the study food due to dietary restrictions for the disease they are being treated for
(4) Subjects who may develop allergies related to the study (Subjects with allergies to milk or soybeans)
(5) Subjects who may experience abdominal symptoms when ingesting the study food or yogurt
(6) Subjects who regularly consume foods containing the relevant ingredients and cannot stop during the study period
(7) Subjects who have participated or plan to participate in other studies within one month from the date of consent acquisition or during the study
(8) Subjects who are judged to be unsuitable as subjects based on their responses to the lifestyle questionnaire
(9) Subjects who are judged to be unsuitable as subjects based on clinical test values and measurements
(10) Subjects who are judged to be unsuitable as subjects by the responsible physician for other reason
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Eiichiro |
| Middle name | |
| Last name | Naito |
Organization
Yakult Honsha Co., Ltd.
Division name
Food Research Laboratory I, Food Research Department, Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo
TEL
042-577-8969
eiichiro-naito@yakult.co.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Kondo |
Organization
EP Mediate Co., Ltd.
Division name
Development department, Trial planning section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-3023-8211
Homepage URL
kondo.mariko793@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.co.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
社会福祉法人新栄会 滝野川病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 17 | 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
| 2025 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065089
