UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054004 |
|---|---|
| Receipt number | R000061653 |
| Scientific Title | Excessive Intake Safety Test of the Research Food -Single Arm Open Label Trial- |
| Date of disclosure of the study information | 2024/04/09 |
| Last modified on | 2024/03/29 12:51:01 |
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Basic information
Public title
Excessive Intake Safety Test of the Research Food
-Single Arm Open Label Trial-
Acronym
Excessive Intake Safety Test of the Research Food
-Single Arm Open Label Trial-
Scientific Title
Excessive Intake Safety Test of the Research Food
-Single Arm Open Label Trial-
Scientific Title:Acronym
Excessive Intake Safety Test of the Research Food
-Single Arm Open Label Trial-
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of the research food by having males and females aged 20 to under 65 consume five times the daily recommended intake of the research food consistently for four weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Physical examination (weight, BMI, blood pressure, pulse)
-Blood test items (hematological examination, biochemical blood test)
-Urinalysis
-Incidence of adverse events and side effects
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
Participants are to take, without chewing, four tablets of the research food after breakfast once a day for four 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.Age: 20 to less than 65 years
2.Japanese males and females
3.Individuals with a BMI of less than 30.0kg/m^2
4.Capable of entering data via a smartphone or PC electronic diary
5.Individuals who have received adequate explanation regarding the trial, can comprehend its contents, and have produced written consent
Key exclusion criteria
1.Currently undergoing pharmacological treatment (except for on-demand medicines)
2.Currently under dietary or exercise therapy supervised by a physician
3.Individuals with a current or past history of serious disease
4.Those aware of their propensity to develop diarrhea
5.Individuals with surgical history on the digestive tract (appendicitis is acceptable)
6.Individuals with current or past food or drug allergies
7.Habitual heavy drinkers (benchmark: daily pure alcohol consumption exceeding 40g)
8.Heavy smokers (benchmark: over 21 cigarettes per day)
9.Individuals who work night shifts in rotating shifts
10.Those planning major lifestyle changes (diet, sleep, exercise habits, etc.) during the test period, such as long trips
11.Currently pregnant or breastfeeding individuals, or those hoping to get pregnant during the trial period
12.Past occurrences of vasovagal reaction or felt unwell immediately after blood collection
13.Participants in other clinical trials of drugs or health foods, within four weeks post-trial, or planning to participate in other clinical trials after consent to participate in this trial
14.Those who performed blood donation or plasma donation within three months before the start of the trial
15.Individuals deemed unsuitable for the trial by the principal investigator or co-principal investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Schikula |
Organization
KINS Co,.Ltd.
Division name
Research and Development Team Manager
Zip code
152-0021
Address
1-33-6-206, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-4580-2285
schikula_shun@yourkins.com
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
sales-contact@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
KINS 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.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
| 2024 | Year | 04 | Month | 09 | 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
| 2024 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061653
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
