UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050832 |
|---|---|
| Receipt number | R000057902 |
| Scientific Title | Research exploring the effectiveness of the Infinity-Force |
| Date of disclosure of the study information | 2023/04/13 |
| Last modified on | 2023/05/22 16:13:54 |
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Basic information
Public title
Research exploring the effectiveness of the Infinity-Force
Acronym
Research exploring the effectiveness of the Infinity-Force
Scientific Title
Research exploring the effectiveness of the Infinity-Force
Scientific Title:Acronym
Research exploring the effectiveness of the Infinity-Force
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to explore the effectiveness of Infinity-Force.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NMN,NAD,NAM,GH,noradrenaline,dopamine,L-dopa,adiponectin,Insulin
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Day 1 Ingest the test food and exercise
Day 2 Exercise only
Day 3 Ingest only the test food
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Males and Females aged 50 to 79 at the time of consent to participate in the study
[2]Individuals whose written informed consent has been obtained
[3]Individuals who can come to the designated examination date and receive the examination
[4]Individuals judged appropriate for the study by the principal
Key exclusion criteria
[1]Individuals using medical products
[2]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.)
[3]Individuals with history of gastrointestinal disorders except for appendicitis
[4]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[5]Individuals who have experienced mood disorder or condition deterioration due to blood sampling in the past
[6]Individuals with serious anemia
[7]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs
[8]Individuals whose life style will change during the test period (ex. travel for a long time)
[9]Individuals who participated in other clinical studies in the past three months
[10]Individuals judged inappropriate for the study by the principal
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Morita |
Organization
Sapporo Anti-Aging Laboratory Co.,Ltd.
Division name
CEO
Zip code
007-0845
Address
2-25-103 Kita 45 East 8-chome, Higashi-ku, Sapporo
TEL
011-776-7505
ymorita707@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazutoshi |
| Middle name | |
| Last name | Shinoda |
Organization
Courage Co.,Ltd.
Division name
CEO
Zip code
103-0014
Address
Park Building 5F, 2-10-10 Nihonbashi Kakigaracho, Chuo-ku, Tokyo
TEL
03-6661-0436
Homepage URL
shinoda@courage-beaute.com
Sponsor or person
Institute
Courage Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Courage 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
Society of Glycative Stress Research
Address
5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-6709-8842
rinri-glycativestress@antiaging-bank.com
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
神宮外苑Woman Life Clinic（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 13 | 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
2
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057902
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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