UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059320 |
|---|---|
| Receipt number | R000067600 |
| Scientific Title | Safety Confirmation Test through Continuous Intake of Test Food -Randomized, placebo-controlled, double-blind, parallel-group comparative trial- |
| Date of disclosure of the study information | 2025/10/07 |
| Last modified on | 2025/09/17 15:50:14 |
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Basic information
Public title
Safety Confirmation Test through Continuous Intake of Test Food
-Randomized, placebo-controlled, double-blind, parallel-group comparative trial-
Acronym
Safety Confirmation Test through Continuous Intake of Test Food
Scientific Title
Safety Confirmation Test through Continuous Intake of Test Food
-Randomized, placebo-controlled, double-blind, parallel-group comparative trial-
Scientific Title:Acronym
Safety Confirmation Test through Continuous Intake of Test Food
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to confirm the safety of the test food when consumed 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: expression number of cases/number of cases analyzed) .
(Week 0, Week 2, Week 4)
Key secondary outcomes
1)Adverse events: number of cases and expression rate of adverse events (expression rate: expression number of cases / number of cases analyzed).(1)
2)Blood pressure, pulsation. (1)
3)Weight, body fat percentage, BMI. (1)
4)Hematologic test. (1)
5)Blood biochemical test. (1)
6)Urine analysis. (1)
7)Doctor's interview. (1)
8)Subject diary. (2)
(1): Week 0, Week 2, Week 4
(2): Record daily from the start of test food intake until the end of the test.
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 bottle in a day; 4 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 bottle 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 males and females aged 20 years or older but under 65 years at the time of obtaining consent to participate in the trial.
2) Healthy individuals without chronic physical conditions, including skin diseases.
3) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer for participation after thorough understanding, and can provide written consent to participate in this trial.
4) Individuals who can attend the designated examination date and undergo the examination.
5) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
1) Individuals currently suffering from any disease and undergoing drug treatment.
2) Individuals with a current medical history involving the digestive organs, liver, kidneys, heart, lungs, mental disorders, sleep disorders, blood disorders, etc., or individuals with a history of serious diseases.
3) Individuals who habitually took medication for disease treatment within the past month (excluding occasional use for headaches, menstrual pain, colds, etc.).
4) Individuals with severe anemia.
5) Individuals with a BMI below 18.5 kg/m2 or above 30 kg/m2.
6) Individuals with systolic blood pressure of 140 mmHg or higher, diastolic blood pressure of 90 mmHg or higher, or pulse rate of 85 beats per minute or higher.
7) Individuals who have donated blood exceeding 200 mL within the past month or 400 mL within the past three months.
8) Individuals who have previously experienced discomfort or deterioration in physical condition following blood collection.
9) Individuals with drug (including alcohol) or food allergies.
10) Individuals regularly consuming specific health foods, foods with functional claims, or health supplements (excluding those who can suspend intake during the trial period at the time of consent).
11) Individuals whose average weekly alcohol consumption exceeds 40g/day for men or 20g/day for women (pure alcohol equivalent).
12) Individuals whose lifestyle may change during the trial period (e.g., due to extended travel).
13) Individuals who are pregnant, breastfeeding, or who may become pregnant during the trial period.
14) Individuals currently participating in another human clinical trial, or individuals who have completed another human clinical trial within the past 3 months.
15) Individuals whose self or family members are employed by companies developing, manufacturing, or selling health/functional foods or cosmetics.
16) Other individuals deemed unsuitable for this trial by the Principal Investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Hirota |
Organization
Asahi Quality & Innovations, Ltd.
Division name
Core Technology Research Institute
Zip code
302-0106
Address
1-21,Midori 1-chome,Moriya-shi,Ibaraki,302-0106
TEL
0297-46-4064
tatsuhiko.hirota@asahi-qi.co.jp
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
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
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 | 07 | 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 | 09 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 19 | 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 | 07 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067600
