UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061437 |
|---|---|
| Receipt number | R000070297 |
| Scientific Title | A study to evaluate the safety of excessive consumption of the test food |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/05/01 19:45:51 |
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Basic information
Public title
A study to evaluate the safety of excessive consumption of the test food
Acronym
A study to evaluate the safety of excessive consumption of the test food
Scientific Title
A study to evaluate the safety of excessive consumption of the test food
Scientific Title:Acronym
A study to evaluate the safety of excessive consumption of the test food
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive consumption of the test food.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
Physical examination, blood tests, urine tests
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oligonol1 g/day,10 cupsiles/day,4 weeks
Interventions/Control_2
Placebo (Dextrin), 10 capsules/day for 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
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Individuals with a BMI of 22.0 kg/m2 or higher but less than 30.0 kg/m2
2.Men and women aged 25 to 64
3.Individuals who have provided written consent to participate in this study
Key exclusion criteria
1.Individuals for whom participation in the trial is difficult due to liver, kidney, or heart disease; respiratory disorders; endocrine disorders; metabolic disorders; neurological disorders; impaired consciousness; diabetes; or other medical conditions
2.Individuals who have undergone surgery or received medication for an illness or injury within two months prior to the start of this trial
3.Individuals currently taking medications to improve glucose metabolism, lipid metabolism, or blood pressure
4.Individuals who regularly consume foods for specific health uses or foods with functional claims (however, this does not apply to those who can suspend consumption during the trial period at the time of obtaining the consent form)
5.Individuals who are unable to consume the test food
6.Individuals who may exhibit allergic reactions to ingredients contained in the test food
7.Individuals currently participating in another clinical trial or planning to participate in one during the duration of this trial
8.Individuals who do not agree with the purpose of this trial as explained in the pre-trial briefing
9.Individuals who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the trial period
10.Any other individuals whom the principal investigator deems unsuitable from the perspective of ensuring subject safety, based on data from health examinations or other sources
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Takeda |
Organization
Kansai University of Welfare Sciences
Division name
Department of Nutritional Sciences for Welll-being Faculty of Health Science for Welfare
Zip code
582-0026
Address
Asahigaoka 3-11-1, Kashiwara, Osaka
TEL
072-978-0088
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Nibun |
Organization
EAS inc.
Division name
Clinical Trial Session
Zip code
236-0028
Address
Susaki-Cho1-10-2F, Kanazawa-ku, Yokohama city, Kanagawa
TEL
045-374-3392
Homepage URL
info@eas-ct.jp
Sponsor or person
Institute
Amino Up Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Amino Up Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KOBUNA ORTHOPEDIC SURGERY
Address
311-2, Gokan-machi, Maebashi, Gunma
Tel
027-261-7600
info@kobunaseikei.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 | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | 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 | 05 | Month | 01 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070297
