UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061961 |
|---|---|
| Receipt number | R000068929 |
| Scientific Title | A Safety Evaluation of Excessive Intake of the Study Food: A Randomized, Open-Label, Placebo-Controlled, Parallel-Group Study |
| Date of disclosure of the study information | 2026/06/28 |
| Last modified on | 2026/06/18 13:51:02 |
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Basic information
Public title
A Safety Evaluation of Excessive Intake of the Study Food: A Randomized, Open-Label, Placebo-Controlled, Parallel-Group Study
Acronym
A Safety Evaluation of Excessive Intake of the Study Food
Scientific Title
A Safety Evaluation of Excessive Intake of the Study Food: A Randomized, Open-Label, Placebo-Controlled, Parallel-Group Study
Scientific Title:Acronym
A Safety Evaluation of Excessive Intake of the Study Food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the safety of the test food by having healthy men and women aged 20 to under 60 consume 600 mL/day ( three times the standard amount ) for four weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, BMI, blood pressure, pulse, hematological tests, blood biochemistry, urinalysis, bowel movement diary, incidence rate of adverse events and side effects
Key secondary outcomes
Gut microbiota, body composition
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
Participants will consume 600 mL of the test food daily for four weeks.
Interventions/Control_2
Participants will consume 600 mL of the placebo food daily for four 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 20 to under 60
2. Japanese men and women
3. BMI less than 30.0 kg/m^2
4. Able to enter electronic diary data via smartphone or PC
5. Able to refrigerate the study food
6. Provided written informed consent after receiving a full explanation and understanding the study
Key exclusion criteria
1. Currently receiving treatment for any illness with medication (including Kampo), or attending medical care (as-needed use permitted)
2. Under dietary or exercise therapy supervised by a physician
3. History or presence of serious liver, kidney, heart, respiratory, endocrine, or metabolic disorders
4. Used antibiotics within one month before consent or plans to use during the study
5. Scheduled for endoscopy, barium meal, H. pylori eradication, or tooth extraction during the study
6. History of gastrointestinal surgery (except appendectomy)
7. Unwilling or unable to consume the study food
8. Previously diagnosed with high blood glucose or elevated triglycerides, or with a family history of diabetes or prediabetes
9. Prone to constipation or diarrhea
10. Regular use of over-the-counter drugs, quasi-drugs, Foods for Specified Health Uses, health foods, or supplements (unless discontinued after consent)
11. History or presence of drug or food allergies, or risk of allergic reaction to the study food
12. Habitual excessive alcohol intake (>=40g pure alcohol/day)
13. Habitual heavy smoking (>=21 cigarettes/day)
14. Shift workers with night shifts
15. Plans to significantly change lifestyle (diet, sleep, exercise, etc.) during the study
16. Plans to travel abroad during the study
17. Unable to refrain from frequent snacking or consuming sugary drinks during the study
18. Pregnant, breastfeeding, or planning pregnancy during the study
19. Presence of metal implants due to surgery
20. Use of a pacemaker or other implantable medical device
21. Participation in another clinical study within one month prior to consent, currently participating, or planning to participate during the study
22. Deemed unsuitable for participation by the principal investigator
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Morita |
Organization
ASAHI QUALITY & INNOVATIONS, LTD.
Division name
Core Technology Laboratories
Zip code
302-0106
Address
1-1-21 Midori, Moriya, Ibaraki 302-0106, Japan
TEL
080-7789-1260
hiroto.morita@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1, Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ASAHI QUALITY & INNOVATIONS, 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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 | 06 | 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
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 | 05 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 28 | 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 | 06 | Month | 18 | Day |
Last modified on
| 2026 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068929
