UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059373 |
|---|---|
| Receipt number | R000067906 |
| Scientific Title | Effects of the test food on swelling in healthy Japanese. |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/10 22:32:07 |
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Basic information
Public title
Effects of the test food on swelling in healthy Japanese.
Acronym
Effects of the test food on swelling in healthy Japanese.
Scientific Title
Effects of the test food on swelling in healthy Japanese.
Scientific Title:Acronym
Effects of the test food on swelling in healthy Japanese.
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the test food on swelling.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower leg volume, Calf circumference
Key secondary outcomes
Visual Analogue Scale
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of test beverage for 8 weeks
Interventions/Control_2
Consumption of control beverage for 8 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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy Japanese women who are 20 to 49 years of age at the time of consent.
Those who feel swelling.
Participants who received sufficient explanation about the purpose and content of the trial, had the ability to consent, volunteered to participate after understanding it well, and agreed to participate in the trial in writing.
Key exclusion criteria
Participants currently taking medication on a daily basis
Participants suffering from a medical condition or requiring continuous medical visits or follow-up monitoring
Participants who regularly consume rooibos tea at least four days a week
Participants who do not like the test or control beverages
Participants who cannot discontinue the intake of health foods (including supplements), foods for specified health uses, foods with nutrient functions, or foods with functional claims during the study period.
Participants who cannot participate in all three designated measurement dates
Participants who cannot stop wearing tight-fitting clothing (skinny jeans, tights, etc.) on the day of the measurement
Participants who cannot remove makeup from their cheeks immediately before the measurement
Participants who are pregnant, intend to become pregnant during the study period, or are breastfeeding
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kobayashi |
Organization
ITO EN, LTD.
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka, Japan
TEL
0548541247
m-kobayasi@itoen.co.jp
Public contact
Name of contact person
| 1st name | Yoshitake |
| Middle name | |
| Last name | Baba |
Organization
ITO EN, LTD.
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka, Japan
TEL
0548-54-1247
Homepage URL
yoshi-baba@itoen.co.jp
Sponsor or person
Institute
-
Institute
Department
Personal name
Funding Source
Organization
-
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
ITO EN, LTD.
Address
21 Mekami, Makinohara-shi, Shizuoka, Japan
Tel
0548-54-1247
-@-
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
| 2025 | Year | 10 | Month | 14 | 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 | 08 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | 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 | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067906
