UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060352 |
|---|---|
| Receipt number | R000069046 |
| Scientific Title | Test to confirm the effects of consuming the test food for three months |
| Date of disclosure of the study information | 2026/01/29 |
| Last modified on | 2026/01/14 16:04:43 |
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Basic information
Public title
Test to confirm the effects of consuming the test food for three months
Acronym
Test to confirm the effects of consuming the test food for three months
Scientific Title
Test to confirm the effects of consuming the test food for three months
Scientific Title:Acronym
Test to confirm the effects of consuming the test food for three months
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Exploratorily evaluate the effects of test food intake on the intestinal environment and the body.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body fat percentage, waist circumference, abdominal visceral fat area, gut short-chain fatty acids, gut putrefactive products, gut microbiota, physical measurements, physiological tests, clinical tests, nutrient intake (sodium, potassium, etc.)
Key secondary outcomes
IPAQ short, OSA-MA, STAI, brief job stress questionnaire, POMS2, VAS, Chalder fatigue scale, MAIA, water intake, bowel movements
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of test food A once a day for 12 consecutive weeks
Interventions/Control_2
Daily intake of test food B once a day for 12 consecutive weeks
Interventions/Control_3
Daily intake of test food C once a day for 12 consecutive weeks
Interventions/Control_4
Non-intervention
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 from 20 to 65 years of age
(2) Subjects whose lunch consists only of the test food and who have no difficulty consuming the entire portion
(3) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study
Key exclusion criteria
Subjects
(1)whose blood pressure in the examination room during screening is at or above the level classified as high blood pressure
(2)who do not have the habit of eating lunch or whose eating habits are extremely irregular
(3)who cannot stop consuming foods and beverages related to the study from the time of the screening
(4)with a medical history of diseases requiring dietary and exercise therapy under a doctor's supervision
(5)who regularly take health supplements and cannot stop taking them during the study period
(6)who regularly use pharmaceutical drugs or quasi-drugs and cannot restrict their intake during the research period
(7)currently receiving medical treatment for gastrointestinal diseases that could affect the research, or those with a history of gastrointestinal surgery
(8)suspected of having, currently being treated for, or with a history of disorders related to bowel movements, sleep, stress, or fatigue
(9)who have shown abnormalities in clinical test values or cardiopulmonary function and are deemed unsuitable for participation in the study
(10)who may be at risk of developing allergies in relation to the research
(11)who require regular medication, those currently undergoing treatment for a disease, and those with a history of severe diseases that required medication treatment
(12)who work in shifts, night shifts, or have irregular daily schedules
(13)Heavy drinkers and smoker
(14)who have participated in other clinical studies from within one month before the date of consent until four weeks after the end of the trial
(15)who plan to become pregnant or breastfeed during the study period
(16)expected to experience significant changes in their living environment during the research period
(17)whose blood donation volume before the start of the study exceeds the regulations
(18)who are aware of imbalances in nutritional intake
(19)deemed inappropriate as subjects by the responsible investigator
(20)using implanted medical electrical devices
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Matsuura |
Organization
NISSIN FOODS HOLDINGS CO., LTD.
Division name
Health Science Research Division
Zip code
192-0001
Address
2100 Tobukimachi, Hachioji-shi, Tokyo
TEL
070-6640-1647
masanori.matsuura@nissin.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo,
TEL
090-4821-1099
Homepage URL
yamamichi.shingo578@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOODS HOLDINGS 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.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
メディカルステーションクリニック (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
| 2025 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 06 | 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
| 2026 | Year | 01 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069046
