UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063081 |
|---|---|
| Receipt number | R000072216 |
| Scientific Title | Safety trial of long-term intake of the test food |
| Date of disclosure of the study information | 2026/09/29 |
| Last modified on | 2026/09/28 18:54:04 |
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Basic information
Public title
Safety trial of long-term intake of the test food
Acronym
Safety trial of long-term intake of the test food
Scientific Title
Safety trial of long-term intake of the test food
Scientific Title:Acronym
Safety trial of long-term 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
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of the active food for 12 weeks
Interventions/Control_2
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 an allergy or hypersensitivity to pine needles, pine needle tea, pine needle extracts, pine nuts, or any other food or ingredient derived from plants of the Pinus genus, or who have a history of experiencing adverse health effects after consuming such products.
4.Subjects who have a history of allergy or hypersensitivity to any ingredients contained in the test food, including pine needle hot-water extract, excipients, capsule coating materials, or other components.
5.Subjects who have any kind of allergy, such as to food or pollen, regardless of the test food. (Especially subjects with an egg allergy.)
6.Subjects with current or history of drug dependence or alcohol dependence.
7.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.
8.Subjects with irregular life rhythms due to night shifts or shift work.
9.Subjects with extremely irregular lifestyle habits such as eating and sleeping.
10.Subjects who are or may be of excessive alcohol consumption.
11.Subjects who have an extremely unbalanced diet.
12.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.
13.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.
14.Subjects with using health foods, supplements, and medications that reduce fatigue.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Iwahashi |
Organization
Arakawa Chemical Industries, Ltd.
Division name
R&D System
Zip code
300-2611
Address
5, Okubo, Tsukuba, Ibaraki (Techno Park Oho)
TEL
029-865-2800
iwahashi@arakawachem.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
mis_21@mis21.co.jp
Sponsor or person
Institute
MIS Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Arakawa Chemical Industries, 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
DiaStep Medical Corporation Home Doctor Clinical Research Ethics Review
Address
Morizumi Building 3F, 22-7 Taishido 4-chome, Setagaya-ku, Tokyo
Tel
03-5433-3255
tomohisa.kato@diastep.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 | 09 | Month | 29 | 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 | 09 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
15.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.
16.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.
17.Subjects who are planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
18.Subjects who have difficulty in recording compliance with various survey forms.
Management information
Registered date
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072216
