UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063533 |
|---|---|
| Receipt number | R000072715 |
| Scientific Title | Study on the Swelling-Reducing Effects of Supplement Intake |
| Date of disclosure of the study information | 2026/11/05 |
| Last modified on | 2026/11/05 17:38:05 |
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Basic information
Public title
Study on the Swelling-Reducing Effects of Supplement Intake
Acronym
Study on the Swelling-Reducing Effects of Supplement Intake
Scientific Title
Study on the Swelling-Reducing Effects of Supplement Intake
Scientific Title:Acronym
Study on the Swelling-Reducing Effects of Supplement Intake
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the swelling-reducing effect of single and 4-week continuous intake of a salt-excreting supplement in adult females aged 18 to 64 who are routinely concerned about facial swelling.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS for facial swelling sensation over the past 4 weeks
Key secondary outcomes
VAS for facial swelling sensation (morning and evening on the day of a single intake) and for leg swelling sensation (over the past 4 weeks, as well as morning and evening on the day of a single intake), change in extracellular water ratio of legs (legs/whole body) (evening minus morning), change in calf circumference (evening minus morning), blood pressure (systolic, diastolic, pulse rate), physical examination (body weight, BMI), dietary survey, urinalysis, blood test (general biochemistry), medical interview, and daily diary
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
Single intake and consecutive intake for 4 weeks of 4 tablets of salt-excreting supplement with water or other beverages. The consecutive intake is to be followed three times a day: before breakfast, lunch, and dinner.
Interventions/Control_2
Single intake and consecutive intake for 4 weeks of 4 tablets of placebo food with water or other beverages. The consecutive intake is to be followed three times a day: before breakfast, lunch, and dinner.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2. Persons who are Japanese females aged 18 to 64 years old at the time of informed consent and are routinely concerned about facial swelling.
3. Persons who have regular menstrual cycles and whose measurement period does not overlap with ovulation, or postmenopausal females.
4. Persons who are among the top 100 in VAS scores regarding facial swelling sensation at screening.
Key exclusion criteria
1. Persons who have chronic illness, receiving medication, have a serious disease history
2. Persons who are allergic to the test food and designated diet
3. Persons who usually take a large amount of test food
4. Persons who usually take medicine (including natriuretics), functional foods for health uses (specified health foods, functional foods, and functional nutrition foods) that may affect swelling or salt absorption/excretion
5. Persons who have participated in other studies within 1 month before the start of the study, or those who intend to participate in another study after consenting to this study
6. Persons who were judged as inappropriate for study participants by the medical director or principal investigator
7. Persons who are breastfeeding, pregnant, or planning or hoping to be pregnant during the study period.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Okamura |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
okamura@hc-sys.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Okamura |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
Homepage URL
okamura@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOYMEDICAL Ltd.
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2026 | Year | 11 | Month | 05 | 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
| 2026 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 11 | Month | 05 | Day |
Last modified on
| 2026 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072715
