UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048415 |
|---|---|
| Receipt number | R000055172 |
| Scientific Title | Effect of the test food intake on quality of life in participants with an advanced immunosenescence: A randomized, placebo controlled, single blind, parallel group dose-finding study |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2022/07/20 18:53:19 |
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Basic information
Public title
Effect of the test food intake on quality of life in participants with an advanced immunosenescence: A randomized, placebo controlled, single blind, parallel group dose-finding study
Acronym
Effect of the test food intake on quality of life in participants with an advanced immunosenescence: A dose-finding study
Scientific Title
Effect of the test food intake on quality of life in participants with an advanced immunosenescence: A randomized, placebo controlled, single blind, parallel group dose-finding study
Scientific Title:Acronym
Effect of the test food intake on quality of life in participants with an advanced immunosenescence: A dose-finding study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effective dosage of the test food on QOL of the participants with advanced immunosenescence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
T scores of the Profile of Mood States 2nd Edition Adult Short Form (POMS2-AS) (Japanese version)
Key secondary outcomes
Immunosenescence markers, Anti-Aging QOL Common Questionnaire, MOS 36-Item Short-Form Health Survey version 2 acute version (Japanese version), Pittsburgh Sleep Quality Index (Japanese version)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
High-dose test food ingestion for 12 consecutive weeks
Interventions/Control_2
Medium-dose test food ingestion for 12 consecutive weeks
Interventions/Control_3
Low-dose test food ingestion for 12 consecutive weeks
Interventions/Control_4
Placebo ingestion for 12 consecutive weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese male and female participants, 40 to 69 years of age.
2. POMS2-AS T score of Fatigue-Inertia >=50, and Vigor-Activity <=50.
3. Relatively high percentage of CD8+ T cells with high senescence-associated beta-galactosidase (SA-beta-gal) activity.
4. Have ability to consent.
Key exclusion criteria
1. Undergone surgical resection of the gastrointestinal tract (Not including appendectomy).
2. Have disease that requires constant medication, or those have a serious medical history that requires medication.
3. Having or had treatment for or diagnosed as autoimmune diseases.
4. Having or had mental illness, chronic fatigue syndrome or sleep disturbance.
5. Diagnosed or suspected as sleep apnea syndrome.
6. Under sleep, stress, and/or fatigue treatment.
7. Night and day shift worker or manual laborer.
8. Regularly taking or planning to take medicine, supplements, FOSHU, and/or food which may affect the results during the study.
9. Possible allergic response related to the study.
10. Is or expected to be pregnant, breastfeeding or desiring to be pregnant during the study period.
11. Excessive drinking habits.
12. Planning to travel abroad during the study period, or planning to go on domestic business trips or domestic trips for more than 7 consecutive days during the study period.
13. Participating in other clinical studies at the beginning of the present study.
14. Judged by the investigator to be inappropriate candidates.
Target sample size
92
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Matsuoka |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3449
matsuoka@fancl.co.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Naito |
Organization
Kenkoin Medical Corporation Foundation
Division name
Kenkoin Clinic
Zip code
104-0061
Address
6-7-4 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-3573-1153
Homepage URL
reiko-naito@kenkoin.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
Clinical Research Ethics Committee of Kenkoin Medical Corporation Foundation
Address
6-7-4 Ginza, Chuo-ku, Tokyo, Japan
Tel
03-3573-1153
isamu-yanase@kenkoin.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 | 12 | Month | 31 | 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
| 2022 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 20 | Day |
Last modified on
| 2022 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055172
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