UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057170 |
|---|---|
| Receipt number | R000065348 |
| Scientific Title | Effects of consumption of the test food on the swelling in healthy Japanese: a randomized, placebo-controlled, double-blind, crossover comparison trial |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2025/05/01 09:06:45 |
* 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
Effects of consumption of the test food on the swelling in healthy Japanese
Acronym
Effects of consumption of the test food on the swelling in healthy Japanese
Scientific Title
Effects of consumption of the test food on the swelling in healthy Japanese: a randomized, placebo-controlled, double-blind, crossover comparison trial
Scientific Title:Acronym
Effects of consumption of the test food on the 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 the 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 "I feel swelling face" at a week after intervention (1w) [Value in the morning]
Key secondary outcomes
1. The amount of change from before intervention of "I feel swelling face" at 1w [Value in the morning]
2. The measured values and the amount of changes from before intervention of "I feel swelling face" at 1w [Value in the evening and the difference between evening and morning values (evening minus morning)]
3. The measured values and the amount of changes from before intervention of Visual Analog Scale (VAS) of "I feel swelling around eyes," "I feel like contour is not sharp," "I feel swelling lower legs," "I feel swelling the ankle (such as my shoes or socks feeling tight)," "my hands and feet are cold," "I feel temporarily down due to severe dark circles under my eyes (Dark circles are a temporary condition caused by poor blood circulation around the eyes)," and "I feel temporarily down due to a tired appearance (A tired appearance refers to looking pale or having a drained complexion)" at 1w [Value in the morning, Value in the evening, and the difference between evening and morning values (evening minus morning)]
4. The measured values and the amount of changes from before intervention of calf circumference and ankle circumference at 1w [Value in the morning, Value in the evening, and the difference between evening and morning values (evening minus morning)]
5. The measured values and the amount of changes from before intervention of body weight and BMI at 1w [Value in the morning, Value in the evening, and the difference between evening and morning values (evening 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
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: one week
<Test 1> Active food
<Test 2> Placebo food
*The intervention sequence is Test 1 to Test 2.
*The washout period is about two weeks.
Interventions/Control_2
Duration: one week
<Test 1> Placebo food
<Test 2> Active food
*The intervention sequence is Test 1 to Test 2.
*The washout period is about two 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals who concerns about swollen face in daily
6. Individuals whose VAS of "I feel swelling face" more than 50 mm in the morning 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 medications (including herbal medicines) or supplements
6. Individuals who are allergic to medicines or foods related to the test product, particularly those allergic to eggs
7. Individuals whose BMI is less than 18.5 kg/m2 or 30 kg/m2 or more
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 have a present condition or have a medical history of drug or alcohol dependence
11. Individuals who drink pure alcohol > 60 g/day at least 4 days per week
12. Individuals who take at least 400 mg/day of caffeine (about 3 mugs of coffee)
13. Individuals who are undergoing treatment for psychiatric disorder (including depressive symptoms) or sleep disorder
14. Individuals who may take high sodium
15. Individuals who are pregnant, lactating, or planning to become pregnant during this study
16. 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
17. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
70
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
Pharma Foods International Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Pharma Foods International 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
| 2025 | Year | 02 | Month | 28 | 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
76
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 | 02 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Statistical Analysis Details>
The subgroups for the analysis set will consist of the populations meeting the following criteria:
a. Subgroup of females (FSS)
The populations of females based on full analysis set (FAS)
b. Subgroup of males (MSS)
The populations of males based on FAS
Management information
Registered date
| 2025 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065348
