UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061471 |
|---|---|
| Receipt number | R000069955 |
| Scientific Title | Safety Study on Excessive Intake of the Test Food - A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial - |
| Date of disclosure of the study information | 2026/05/10 |
| Last modified on | 2026/04/02 11:00:49 |
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Basic information
Public title
Safety Study on Excessive Intake of the Test Food
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -
Acronym
Safety Study on Excessive Intake of the Test Food
Scientific Title
Safety Study on Excessive Intake of the Test Food
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -
Scientific Title:Acronym
Safety Study on Excessive Intake of the Test Food
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety of excessive intake of the test food by having subjects consume three times the recommended daily intake for four weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed)
Key secondary outcomes
1) Trends and Changes in Physical Examination Findings
-Blood pressure/pulse rate
-Weight/body fat percentage/BMI
2) Trends and Changes in Laboratory Test Results
-Hematological tests
-Biochemical blood tests
-General urinalysis
3) Medical consultation
4) Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed)
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
Oral ingestion of a test food (3 packets in a day; 4 weeks).
Interventions/Control_2
Oral ingestion of a placebo food (3 packets in a day; 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 men and women aged 20 to 64 at the time of obtaining consent to participate in the study.
2) Individuals who have received a thorough explanation of the study's purpose and content, possess the capacity to consent, have voluntarily applied to participate after fully understanding the study, and are able to provide written consent to participate in the study.
3) Individuals who are able to visit the facility on the designated examination date and undergo the examination.
4) Individuals deemed suitable for participation in the study by the principal investigator.
Key exclusion criteria
Individuals
1) currently suffering from any medical condition and undergoing drug treatment.
2) with a current history of mental illness, sleep disorders, hypertension, diabetes, or dyslipidemia, or a history of severe cases of these conditions.
3) with a history of serious conditions affecting the liver, kidneys, heart, lungs, blood, or digestive system.
4) who regularly take medication or have a history of taking medication for the treatment of medical conditions within the past month (excluding occasional use for conditions such as headaches, menstrual cramps, or colds) .
5) with a BMI of 30 kg/m2 or higher.
6) who may experience allergic reactions to ingredients contained in the test food, or who may experience allergic reactions to other foods or medications.
7) who have donated blood or similar fluids in amounts exceeding 200 mL within the past month, or 400 mL within the past three months.
8) whose daily alcohol consumption exceeds an average of 40 g of alcohol per day for men and 20 g of alcohol per day for women, calculated on a weekly basis.
9) whose daily routines may change during the study period (e.g., night shifts, extended travel) .
10) who currently consume, or have consumed within the past three months, health functional foods, health foods, or supplements on a regular basis, or who plan to consume such products during the study period.
11) who are pregnant, breastfeeding, or may become pregnant, or who intend to become pregnant during the study period.
12) currently participating in another clinical trial, or those who have participated in another clinical trial within the past three months.
13) whose family members or themselves are employed by a company that develops, manufactures, or sells health foods, functional foods, or cosmetics.
14) 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 | Yoko |
| Middle name | |
| Last name | Onchi |
Organization
DAICEL CORPORATION
Division name
R&D Headquarters Business Development Center
Zip code
671-1283
Address
1239, Shinzaike, Aboshi-ku, Himeji, Hyogo
TEL
079-274-4068
yk_onchi@jp.daicel.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
DAICEL CORPORATION
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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 | 05 | Month | 10 | 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 | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 06 | 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 | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069955
