UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059396 |
|---|---|
| Receipt number | R000067792 |
| Scientific Title | A Study on the Effects of Continuous Intake of the Test Food on Alleviating Social Isolation and Loneliness: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study/Trial |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/14 16:50:23 |
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Basic information
Public title
A Study on the Effects of Continuous Intake of the Test Food on Alleviating Social Isolation and Loneliness
Acronym
A Study on the Effects of Continuous Intake of the Test Food on Alleviating Social Isolation and Loneliness
Scientific Title
A Study on the Effects of Continuous Intake of the Test Food on Alleviating Social Isolation and Loneliness: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study/Trial
Scientific Title:Acronym
A Study on the Effects of Continuous Intake of the Test Food on Alleviating Social Isolation and Loneliness
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 4-week continuous intake of the test food on alleviation of social isolation and loneliness, as well as on perceived social health, in healthy participants experiencing social isolation and loneliness through a randomized, double-blind, placebo-controlled, parallel-group study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
UCLA Loneliness Scale
Key secondary outcomes
(1) SF-36v2 Japanese version
(2) WHO-DAS2.0
(3) Serum serotonin, serum oxytocin
(4) Daily step count
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
4-week intake of test foods
Interventions/Control_2
4-week intake of placebo foods
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged between 20 and 64 years at the time of obtaining informed consent.
2. Healthy Japanese men and women.
3. Individuals who feel socially isolated and/or lonely.
4. Individuals who have the capacity to consent, have received sufficient explanation regarding the purpose and content of the study, have fully understood the information, and voluntarily agreed to participate by providing written informed consent.
Key exclusion criteria
1. Individuals receiving medical treatment for psychiatric disorders or autonomic nervous system disorders, or those scheduled to receive such treatment or medication during the study period.
2. Individuals with chronic diseases who are receiving medical treatment.
3. Individuals with a serious past history of cerebrovascular, cardiac, hepatic, renal, hematological, or endocrine diseases.
4. Individuals with a serious past history of gastrointestinal diseases.
5. Individuals judged by the principal investigator to have a psychiatric disorder based on the score of SDS.
6. Individuals with a history of feeling unwell or experiencing health deterioration due to blood collection.
7. Individuals who may develop an allergic reaction to the test food.
8. Men or women who donated 200 mL of blood within 4 weeks or component blood within 2 weeks prior to the on-site screening test; women who donated 400 mL of blood within 16 weeks prior to the screening; or men who donated 400 mL of blood within 12 weeks prior to the screening.
9. Smokers.
10. Habitual alcohol consumers.
11. Individuals with extremely irregular sleep patterns or dietary habits.
12. Individuals who cannot discontinue the intake of Foods for Specified Health Uses (FOSHU), Foods with Function Claims, or other health foods during the study period.
13. Individuals who are expected to experience major changes in living environment, or significant changes in dietary or exercise habits during the study period.
14. Women who are breastfeeding, pregnant, possibly pregnant, or planning to become pregnant during the study period.
15. Individuals currently participating in another clinical trial, those who have participated in another clinical trial within 4 weeks prior to the on-site screening test, or those planning to participate in another clinical trial during the study period.
16. Any other individuals judged by the principal investigator to be inappropriate as study participants.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Kimoto |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
Homepage URL
kimoto@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Oryza Oil & Fat Chemical Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Watanabe Hospital
Address
1-5-16 Haneda, Ota-ku, Tokyo, Japan
Tel
03-3741-0223
wnb.cto@gmail.com
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
医療法人社団 渡辺病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067792
