UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059387 |
|---|---|
| Receipt number | R000067603 |
| Scientific Title | Human Safety Evaluation of Excessive Intake of the Test Food -A randomized, double-blind, placebo-controlled, parallel-group trial- |
| Date of disclosure of the study information | 2025/10/19 |
| Last modified on | 2025/09/18 16:10:42 |
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Basic information
Public title
Human Safety Evaluation of Excessive Intake of the Test Food
-A randomized, double-blind, placebo-controlled, parallel-group trial-
Acronym
Human Safety Evaluation of Excessive Intake of the Test Food
Scientific Title
Human Safety Evaluation of Excessive Intake of the Test Food
-A randomized, double-blind, placebo-controlled, parallel-group trial-
Scientific Title:Acronym
Human Safety Evaluation of 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 is to confirm the safety of the test food when consumed continuously for four weeks by healthy men and women.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Adverse events: number of cases and incidence rate of adverse events (incidence rate: number of cases/number of cases analyzed)
2)Side effects: number of cases and incidence rate of side effects (incidence rate: number of cases/number of cases analyzed)
3)Physical examination (Body weight / Body fat percentage / Body mass index, Blood pressure / Pulse rate)
4)Clinical examination (Hematological test, Biochemistry test, 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
Oral intake of the test food (1 packet in a day; 4 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 packet 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged between 18 and 65 years old at the time of obtaining consent to participate in the study.
2) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
Key exclusion criteria
1) Individuals currently suffering from any chronic disease and receiving drug treatment.
2) Individuals with a history of serious illnesses.
3) Individuals who are unable to participate in the study due to liver, kidney, or heart disease, respiratory disorders, endocrine disorders, metabolic disorders, neurological disorders, impaired consciousness, diabetes, or other illnesses.
4) Individuals with a history of gastrointestinal diseases or gastrointestinal surgery that affect digestion and absorption (excluding appendicitis) .
5) Individuals with a current or past history of drug or food allergies.
6) Individuals with a systolic blood pressure of less than 90 mmHg.
7) Individuals with severe anemia.
8) Individuals who have donated more than 200 mL of blood in the past month or more than 400 mL in the past three months.
9) Individuals who have previously experienced ill health or worsening physical conditions after blood collection.
10) Individuals who regularly consume foods for specified health uses, foods with functional claims, or health foods.
11) Individuals who are pregnant, lactating, or may become pregnant.
12) Individuals who are heavy smokers (average smoking of 21 or more cigarettes per day).
13) Individuals whose daily alcohol intake exceeds 60 g/day of pure alcohol per week.
14) Individuals with a history or current medical history of drug or alcohol dependence.
15) Individuals who may change their lifestyle during the study period (night shifts, long-term travel, etc.).
16) Individuals currently participating in a study involving the intake of other foods or medications, or the application of cosmetics or medications, within the last four weeks of completing a study, or individuals who intend to participate.
17) Individuals judged inappropriate for the study by the principal.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
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
Morinaga Milk Industry 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
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
| 2025 | Year | 10 | 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
| 2025 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 15 | 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 | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067603
