UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062595 |
|---|---|
| Receipt number | R000071652 |
| Scientific Title | Study on the Mitigating Effect of Test Food Intake on Edema - A randomized, double-blind, placebo-controlled, crossover study- |
| Date of disclosure of the study information | 2026/08/19 |
| Last modified on | 2026/08/17 18:04:40 |
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Basic information
Public title
Study on the Mitigating Effect of Test Food Intake on Edema
- A randomized, double-blind, placebo-controlled, crossover study-
Acronym
Study on the Mitigating Effect of Test Food Intake on Edema
- A randomized, double-blind, placebo-controlled, crossover study-
Scientific Title
Study on the Mitigating Effect of Test Food Intake on Edema
- A randomized, double-blind, placebo-controlled, crossover study-
Scientific Title:Acronym
Study on the Mitigating Effect of Test Food Intake on Edema
- A randomized, double-blind, placebo-controlled, crossover study-
Region
| Japan |
Condition
Condition
Healthy men and women aged 20 to 64
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous intake of a food product containing 100 mg of Ginger Extract Powder E on facial puffiness in healthy male and female subjects aged 20 to 64 who perceive facial puffiness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale (VAS) for facial swelling
Key secondary outcomes
Facial volume measured by VECTRA Handy H1, Facial skin hydration measured by Corneometer, Lower leg volume measured by Perometer, Calf circumference measured by Perometer, Other subjective symptom questionnaires.
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food intake
Interventions/Control_2
Control food intake
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)Healthy male and female subjects aged 20 to under 65 years.
2)Subjects who subjectively perceive facial swelling.
3)Subjects who fully understand the purpose and content of the study and provide written informed consent of their own free will.
Key exclusion criteria
1)Subjects with a history or current diagnosis of diabetes, hepatic disease, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious diseases
2)Subjects who have undergone gastrointestinal surgery, excluding minor procedures (e.g., appendectomy) judged by the principal investigator to have no impact on the study
3)Subjects with clinically significant abnormalities in liver or renal function tests at screening
4)Subjects currently undergoing treatment for any disease
5)Subjects with a history of severe allergy to foods or medications, or with a known allergy to ginger
6)Subjects presenting with symptoms of anemia
7)Women who are pregnant, lactating, possibly pregnant, or planning to become pregnant during the study period
8)Subjects using hormonal agents or low-dose oral contraceptives
9)Subjects who engage in regular strenuous exercise, or those currently on a weight-loss diet
10)Subjects unable to abstain during the study period from health foods (including Foods for Specified Health Uses [FOSHU] and Foods with Function Claims), quasi-drugs, or foods/supplements claiming to improve swelling, blood flow, or sensitivity to cold, or claiming to have diuretic effects
11)Subjects undergoing continuous treatment with medications (including over-the-counter [OTC] and prescription drugs), excluding cases judged by the principal investigator to have no impact on the study
12)Subjects currently participating in, or scheduled to participate in, other clinical studies at the start of this study
13)Subjects judged unsuitable as participants based on the lifestyle questionnaire, medical interview, or screening test results
14)Subjects otherwise judged unsuitable for the study by the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Nakamura |
Organization
Ikeda Food Research Co., Ltd.
Division name
Food Science and Technology Institute
Zip code
721-0956
Address
95-7, Minookicho, Fukuyama-city, Hiroshima
TEL
084-957-3411
n.nakamura@ikedatohka.co.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Otake |
Organization
feileB Co., Ltd
Division name
Clinical Research Support dev.
Zip code
170-0013
Address
1-18-1, Higashiikebukuro Toshima-ku Tokyo Japan
TEL
03-4332-1770
Homepage URL
otake@feileb.jp
Sponsor or person
Institute
feileB Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Ikeda Food Research Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee
Address
Hakutyo Build. 2F,2-1-2, Shinjuku,Shinjuku-ku, Tokyo
Tel
06-6882-1130
ethics_board@drc-web.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
| 2026 | Year | 08 | Month | 19 | 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 | 07 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 24 | 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 | 08 | Month | 17 | Day |
Last modified on
| 2026 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071652
