UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055123 |
|---|---|
| Receipt number | R000062973 |
| Scientific Title | Effect of the test food intake on immunosenescence markers in Japanese female: A randomized, placebo controlled, double blind, parallel group comparison study |
| Date of disclosure of the study information | 2024/08/02 |
| Last modified on | 2025/02/06 16:40:57 |
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Basic information
Public title
Effect of the test food intake on immunosenescence markers in Japanese female: A randomized, placebo controlled, double blind, parallel group comparison study
Acronym
Effect of the test food intake on immunosenescence markers in Japanese female
Scientific Title
Effect of the test food intake on immunosenescence markers in Japanese female: A randomized, placebo controlled, double blind, parallel group comparison study
Scientific Title:Acronym
Effect of the test food intake on immunosenescence markers in Japanese female
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect and safety of the test food on immunosenescence.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Immunosenescence markers; Proportion of CD8+ T cells with high senescence-associated beta-galactosidase (SA-beta-gal) activity.
Key secondary outcomes
Other immunosenescence markers ;
CD3+ T cells / lymphocyte ratio, CD4+ T cells / lymphocyte ratio, CD8+ T cells / lymphocyte ratio
CD4+ T cells / CD8+ T cells ratio
proportion of CD4+ T cells with high senescence-associated beta-galactosidase (SA-beta-gal) activity
naive T cells / CD4+ T cells ratio, central memory T cells / CD4+ T cells ratio, effector memory T cells / CD4+ T cells ratio, TEMRA T cells / CD4+ T cells ratio, PD-1 / CD4+ T cell ratio,
naive T cells / CD8+ T cells ratio, central memory T cells / CD8+ T cells ratio, effector memory T cells / CD8+ T cells ratio,
PD-1 / CD8+ T cell ratio
Subgroup analysis based on Baseline data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food containing Plant extract ingestion for 8 consecutive weeks
Interventions/Control_2
Intake of placebo for 8 consecutive weeks
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1. Japanese female participants, 40 to 59 years of age at the time obtaining consent.
2. Relatively high proportion of CD8+ T cells with high senescence-associated beta-galactosidase (SA-beta-gal) activity and relatively lower proportion of CD8+ naive T cells.
3. Have ability to consent.
Key exclusion criteria
1. Participants who undergone surgical resection of the gastrointestinal tract (Not including appendectomy).
2. Participants who have disease that requires constant medication, or those have a serious medical history that requires medication.
3. Participants with autoimmune diseases or a history of autoimmune diseases
4. Participants who self-report having mental illness, chronic fatigue syndrome, insomnia, or a history of such illnesses.
5. Participants who diagnosed or suspected as sleep apnea syndrome.
6. Participants undergoing treatment related to sleep, stress, and/or fatigue.
7. Night and day shift worker or manual laborer.
8. Participants who regularly taking or planning to take medicine, supplements, FOSHU, and/or food which may affect the results during the study.
9. Participants having possibilities for emerging allergy relates to the study
10. Participants who are planning to become pregnant or becoming pregnant or lactating during the study.
11. Heavy drinkers of alcohol or excessive smokers
12. Participants who are planning to travel abroad during the study period, or who are planning of long-term domestic trip for more than one week in study period.
13. Participants who are participating in other clinical studies at the beginning of the present study.
14. Participants who are judged as unsuitable for the study based on the results of lifestyle questionnaire
15. Participants whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range
16. Participants judged as unsuitable for the study by the investigator for other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Sachiyuki |
| Middle name | |
| Last name | Teramoto |
Organization
FANCL Corporation
Division name
Research Institute, Functional Food Research Institute
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3425
sateramoto@fancl.co.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Shimada |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
090-5219-2774
Homepage URL
shimada.hiroyasu767@eps.co.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
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, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062973
