UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053276 |
|---|---|
| Receipt number | R000060809 |
| Scientific Title | Safety of long-term consumption of Tablets. |
| Date of disclosure of the study information | 2024/01/08 |
| Last modified on | 2024/03/14 19:09:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety of long-term consumption of Tablets.
Acronym
Safety of long-term consumption of Tablets.
Scientific Title
Safety of long-term consumption of Tablets.
Scientific Title:Acronym
Safety of long-term consumption of Tablets.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of consumption of Tablets of recommended daily intake for 12 weeks on healthy adult males and females.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before and 4, 8,12 weeks after intake and Adverse events thorough the study
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
Consumption of Tablets, quantity of recommended daily intake, 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females from 20 to 64 years of age
Key exclusion criteria
(1) Subjects who are taking healthy foods related functional substance for at least one day a week at the start of this study
(2) Subjects who have abnormalities in clinical examination values, cardiopulmonary function, or have a history of serious kidney or gastrointestinal diseases
(3) Subjects who may develop allergies in relation to this study
(4) Subjects who have a disease that requires constant medication (whether external or internal), those who have a disease under treatment (except for dry eye and dental caries treatment), those who have a history of serious disease that required medication
(5) Subjects whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range
(6) Subjects who work in shifts, work late at night, or have an irregular daily rhythm
(7) Subjects who are participating in the other study within 1 month before the start of this study
(8) Subjects who plan to become pregnant or breastfeed during the study period
(9) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey
(10) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ueno |
Organization
MEGMILK SNOW BRAND Co.,Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2 Minamidai, Kawagoe, Saitama
TEL
049-242-8165
hiroshi-ueno@meg-snow.com
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Miyayama |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center Foods Department
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-3023-8210
Homepage URL
miyayama.saki392@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@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
社会福祉法人新栄会 滝野川病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 08 | 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
20
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
| 2023 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 24 | 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 | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060809
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
