UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048786 |
|---|---|
| Receipt number | R000055584 |
| Scientific Title | Changes in Urinary Markers by Intake of Anti-Aging Foods in Japanese Adult Male and Female |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/07/12 16:16:30 |
* 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
Changes in Urinary Markers by Intake of Anti-Aging Foods in Japanese Adult Male and Female
Acronym
Changes in Urinary Markers by Intake of Anti-Aging Foods in Japanese Adult Male and Female
Scientific Title
Changes in Urinary Markers by Intake of Anti-Aging Foods in Japanese Adult Male and Female
Scientific Title:Acronym
Changes in Urinary Markers by Intake of Anti-Aging Foods in Japanese Adult Male and Female
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of changes in urinary markers after ingestion of anti-aging foods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in urinary aging markers after 12 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of anti-aging food for 12 weeks
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
| 35 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women between the ages of 35 and 70
2) BMI between 18.5 kg/m2 and 25 kg/m2
Key exclusion criteria
1) Have a history of serious medical history or previous resection of the gastrointestinal tract (excluding appendectomy)
2) Currently taking medication or being treated by a physician
3) Intend to receive any medical treatment or medication during the study period
4) Plan to consume health foods or supplements other than the study food after consent is given.
5) Unable to consume the test food due to preferences, allergies, etc.
6) Pregnant women (including those who may become pregnant) or nursing mothers
7) Heavy drinkers of alcohol or excessive smokers
8) Any other person who is deemed by the study staff to be inappropriate to participate in the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ochou |
Organization
FANCL Research Institute
Division name
Health Science research center
Zip code
2440806
Address
Yokohama, Kanagawa, Japan
TEL
045-820-3659
tsubokawa_masaya@fancl.co.jp
Public contact
Name of contact person
| 1st name | masaya |
| Middle name | |
| Last name | tsubokawa |
Organization
FANCL Research Institute
Division name
Health Science research center
Zip code
2440806
Address
Yokohama, Kanagawa, Japan, 12-13
TEL
045-820-3659
Homepage URL
tsubokawa_masaya@fancl.co.jp
Sponsor or person
Institute
FANCL Research Institute
Institute
Department
Personal name
Funding Source
Organization
FANCL Research Institute
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
FANCL Clinical Research Review Committee
Address
Yokohama, Kanagawa, Japan, 12-13
Tel
045-820-3659
tsubokawa_masaya@fancl.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
| 2022 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2022 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055584
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
