UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060175 |
|---|---|
| Receipt number | R000068818 |
| Scientific Title | Evaluation of the safety of excessive intake of a test product -A randomized, double-blind, placebo-controlled, parallel-group trial- |
| Date of disclosure of the study information | 2025/12/23 |
| Last modified on | 2025/12/23 11:12:26 |
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Basic information
Public title
Evaluation of the safety of excessive intake of a test product
Acronym
Evaluation of the safety of excessive intake of a test product
Scientific Title
Evaluation of the safety of excessive intake of a test product -A randomized, double-blind, placebo-controlled, parallel-group trial-
Scientific Title:Acronym
Evaluation of the safety of excessive intake of a test product
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive intake at five times the recommended daily intake of a test product for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･Number and occurrence rate of side effects
･Number and occurrence rate of adverse events
･Physical measurements (weight, BMI)
･Physiological tests (body temperature, blood pressure, pulse rate)
･Clinical tests (hematological tests, blood biochemistry tests, urinalysis)
Key secondary outcomes
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
Ingestion of active food for 4 weeks
Interventions/Control_2
Ingestion of placebo food for 4 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese men and women aged 20 to under 65 at the time of obtaining consent to participate in the trial
2. Individuals able to visit the trial hospital on the scheduled visit date
3. Individuals who fully understand the purpose and content of this trial and consented in writing prior to trial starts
Key exclusion criteria
1. Individuals with dysphagia
2. Individuals who have previously experienced feeling sick or worsening physical condition due to blood draws
3. Individuals whose average weekly alcohol consumption, converted to pure alcohol, exceeds 40 g/day
4. Smokers
5. Individuals who have irregular daily routines or eating habits
6. Individuals who are undergoing medical treatment due to illness or injury, or who are scheduled to undergo surgery during the trial period (excluding those prescribed medication for temporary symptoms such as colds or hay fever)
7. Individuals with a history or current presence of serious diseases of heart, liver, or kidney disease (including cases where it is a complication of another disease)
8. Individuals with a history or current presence of serious diseases such as cancer or tuberculosis
9. Individuals who are positive or suspected to be positive in infectious disease tests
10. Individuals at risk of showing allergic symptoms upon food
11. Individuals regularly consuming medications, quasi-drugs
12. Individuals regularly consuming specific health foods, functional foods, nutritional supplements (e.g. capsule supplements) (excluding those who can suspend consumption at the time of informed consent)
13. Individuals who donated or drawn 200 mL or more blood within one month prior to the screening test or plan to donate blood during the trial period
14. Individuals working rotating shifts, including night shifts, or night shift workers
15. Individuals participating in another clinical trial within the past one month
16. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period
17. Any other individuals deemed ineligible for this trial by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi, Japan
TEL
0287-36-2935
G167_0@kagome.co.jp
Public contact
Name of contact person
| 1st name | Toyotada |
| Middle name | |
| Last name | Ashino |
Organization
TRANSGENIC INC.
Division name
Clinical Research Dept.
Zip code
061-1405
Address
452-1 Toiso, Eniwa, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
toyotada.ashino@transgenic.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME 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
KAGOME CO.,LTD. Research Ethics Review Committee
Address
Nihonbashi Hamacho F Tower, 3-21-1 Nihonbashi Hamacho, Chuo-ku, Tokyo, Japan
Tel
03-5623-8501
IRB@kagome.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
| 2025 | Year | 12 | Month | 23 | 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
| 2025 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068818
