UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052320 |
|---|---|
| Receipt number | R000059721 |
| Scientific Title | A Study on the Effect of Test food on Subjective symptoms in Healthy Men. |
| Date of disclosure of the study information | 2023/09/27 |
| Last modified on | 2024/10/11 10:08:35 |
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Basic information
Public title
A Study on the Effect of Test food on Subjective symptoms in Healthy Men.
Acronym
A Study on the Effect of Test food on Subjective symptoms in Healthy Men.
Scientific Title
A Study on the Effect of Test food on Subjective symptoms in Healthy Men.
Scientific Title:Acronym
A Study on the Effect of Test food on Subjective symptoms in Healthy Men.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of test food on subjective symptoms in healthy men
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective symptom questionnaire
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
Test food , 2 weeks consumption
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
| 35 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Male subjects ranging in age from 20 to 35 at informed consent.
(2) Subjects who are aware of feelings of decreased vitality, etc.
(3) Subjects who can make self-judgment and voluntarily gave informed consent electromagnetically.
Key exclusion criteria
(1) Subjects who meet any of the following:
(a) suffering from heart, liver, or kidney disease (including complications of other diseases)
(b) having a history of cardiovascular disease
(c) diabetes
(d) allergic to the test food.
(2) Subjects who consume soft drinks, nutritional drinks, foods with health claims, and supplements containing the ingredients contained in the test food at least 5 times a week.
(3) Subjects who have experienced any change in their physical condition due to soft drinks, nutritional drinks, foods with health claims, and supplements containing the ingredients contained in the test food and who avoid taking them.
(4) Subjects who have difficulty in taking the test food continuously.
(5) Subjects who are likely to undergo major life changes, travel, long vacations, etc. during the test period.
(6) Subjects who have a chronic disease and regularly use medications.
(7) Subjects who have been judged by the principal investigator or sub-inbestigator that treatment for chronic diseases is necessary.
(8) Subjects being under other clinical tests, or partook in those within the past four weeks, or will join those after the consent.
(9) Others who were judged as inappropriate for participation by the principal/sub investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Minami |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-3182-6161
Hisako_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Karasudani |
Organization
Suntory beverage & Food limited.
Division name
Development & Designed Department
Zip code
211-0067
Address
13-2 Imaikami-cho, Nakahara-ku, Kawasaki, Kanagawa, JAPAN
TEL
050-3182-6840
Homepage URL
Yukie_Karasudani@suntory.co.jp
Sponsor or person
Institute
Suntory beverage & Food limited.
Institute
Department
Personal name
Funding Source
Organization
Suntory beverage & Food limited.
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
05-2734-8885
soumu@hc-sys.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
| 2023 | Year | 09 | Month | 27 | 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
38
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 | 09 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059721
