UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059140 |
|---|---|
| Receipt number | R000067652 |
| Scientific Title | Effects of consumption of the test food on swelling in healthy Japanese: a randomized, placebo-controlled, double-blind, crossover comparison study |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2025/12/03 17:12:22 |
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Basic information
Public title
Effects of consumption of the test food on swelling in healthy Japanese
Acronym
Effects of consumption of the test food on swelling in healthy Japanese
Scientific Title
Effects of consumption of the test food on swelling in healthy Japanese: a randomized, placebo-controlled, double-blind, crossover comparison study
Scientific Title:Acronym
Effects of consumption of the test food on swelling in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on swelling in healthy Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of swelling volume (evening lower leg volume minus morning lower leg volume)
Key secondary outcomes
1. The measured values of the lower leg volume in the morning and evening
2. The measured values of Visual Analogue Scale (VAS) for "I feel swelling face (cheeks or face line)," "I feel swelling around eyes," "I feel swelling calves," "I feel swelling the ankle (such as my socks feeling tight)," "I feel my complexion looks poor," and "I feel dark circles under my eyes" (Measurements include values in the morning, evening, and the following morning, as well as the difference between evening and morning values [evening minus morning], and between following morning and morning values [following morning minus morning])
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
<Duration>
Single administration (two periods)
<Test products>
Test 1: Active food
Test 2: Placebo food
Lunch on each test day: Prescribed food
<Intervention sequence>
*Test 1 followed by Test 2.
*The washout period will be two weeks.
<Administration>
*Consume one capsule of the active food or placebo food with water after completing the morning measurements in each test of this study.
*The prescribed meal will be consumed 2 hours after the start of the loading phase in each test.
*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.
Interventions/Control_2
<Duration>
Single administration (two periods)
<Test products>
Test 1: Placebo food
Test 2: Active food
Lunch on each test day: Prescribed food
<Intervention sequence>
*Test 1 followed by Test 2.
*The washout period will be two weeks.
<Administration>
*Consume one capsule of the active food or placebo food with water after completing the morning measurements in each test of this study.
*The prescribed meal will be consumed 2 hours after the start of the loading phase in each test.
*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged between 20 and 64
4. Healthy individuals
5. Individuals who are concerned about lower leg swelling
6. Individuals whose BMI is >= 18.5 kg/m2 and < 30.0 kg/m2 at screening
7. Individuals with a large diurnal variation in lower leg volume (swelling) at screening
8. Individuals whose systolic blood pressure is < 130 mmHg and diastolic blood pressure is < 90 mmHg at screening
9. Individuals with no abnormalities in kidney function as determined by urinalysis at screening
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking or using medicines (including herbal medicines) or supplements
6. Individuals who are allergic to medicines or foods related to the test product
7. Individuals with drinking habits exceeding moderate consumption
8. Individuals whose lifestyles are irregular due to working a late-night shift or others
9. Individuals who are undergoing exercise or alimentary therapy under medical supervision
10. Individuals who are pregnant, lactating, or planning to become pregnant during this study
11. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
12. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Fujicco Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Fujicco Co., 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 ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 30 | 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
44
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
| 2025 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Statistical analysis details>
The subgroups will be constructed based on the factors in the following variables.
Gender: Male / female
"I feel swelling face" (VAS) in the morning at screening: 50 mm or more / less than 50 mm
Management information
Registered date
| 2025 | Year | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067652
