UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058900 |
|---|---|
| Receipt number | R000067359 |
| Scientific Title | Safety trial of 12-week continuous intake of the test food |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/09/10 15:57:06 |
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Basic information
Public title
Safety trial of 12-week continuous intake of the test food
Acronym
Safety trial of 12-week continuous intake of the test food
Scientific Title
Safety trial of 12-week continuous intake of the test food
Scientific Title:Acronym
Safety trial of 12-week continuous intake of the test food
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of twelve weeks of continuous consumption of the test food in Japanese men and women between the ages of 20 and 65.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vital signs, physical measurements, blood biochemistry, hematology, urinalysis, adverse events
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
Intake of the active food for 12 weeks
Interventions/Control_2
Intake of the placebo food for 12 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.Japanese men and women between 20 and 65 years of age at the time of obtaining written informed consent.
2.Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study in writing.
Key exclusion criteria
1.Subjects who are taking medication or under medical treatment.
2.Subjects who are under exercise therapy or dietetic therapy.
3.Subjects who have any kind of allergy, such as to food or pollen, regardless of the test food. (Especially subjects with an egg allergy.)
4.Subjects with current or history of drug dependence or alcohol dependence.
5.Subjects who are hospitalized for mental disorders (depression, etc.) or sleep disorders(insomnia, sleep apnea, etc.), or have a history of mental disorders in the past.
6.Subjects with irregular life rhythms due to night shifts or shift work.
7.Subjects with extremely irregular lifestyle habits such as eating and sleeping.
8.Subjects who are or may be of excessive alcohol consumption.
9.Subjects who have an extremely unbalanced diet.
10.Subjects with serious current or past medical conditions such as brain disease, malignancy, immunological disorders, diabetes, liver disease (including hepatitis), kidney disease, heart disease, thyroid disorders, adrenal gland disorders, or other metabolic diseases.
11.Subjects who have been previously advised of abnormalities or concerns regarding liver function parameters (such as gamma-GTP, AST, or ALT) during a health checkup or similar medical examination.
12.Subjects with using health foods, supplements, and medications that reduce fatigue.
13.Subjects who have participated in other clinical trials (research) within 3 months from the date of consent acquisition or who plan to participate in other clinical trials (research) during the trial period.
14.Subjects who have collected 200 mL of blood or donated more than 400 mL of blood within 3 months from the date of consent acquisition.
15.Subjects who are planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
16.Subjects who have difficulty in recording compliance with various survey forms.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Yamashita |
Organization
Pharma Foods International Co., Ltd.
Division name
R&D Department
Zip code
615-8245
Address
1-49, Goryo-ohara, Nishikyo-ku, Kyoto-shi, Kyoto, Japan
TEL
075-748-9829
y-yamashita@pharmafoods.co.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
MIS Co.,Ltd.
Division name
Clinical Development Department
Zip code
531-0072
Address
8F,Sho-rei Building, 3-4-14 Toyosaki, Kitaku, Osaka-Shi, Osaka, Japan
TEL
06-7878-6780
Homepage URL
m.matsuoka@mis21.co.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
others
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
Medical Corporation Takahashi Internal Medicine Clinic Research Ethics Review Board
Address
Chikasa Daiichi Building 1F, Higashi Koigakubo6-2-6, Kokubunnji, Tokyo Japan
Tel
03-6869-4145
jimukyoku@medireco.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 | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
"(Exclusion criteria continued)
17.Subjects who are judged to be unsuitable as subjects based on clinical laboratory values and measurements at the time of SCR.
18.Other subjects who are judged by the investigator to be unsuitable as subjects."
Management information
Registered date
| 2025 | Year | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067359
