UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052321 |
|---|---|
| Receipt number | R000059730 |
| Scientific Title | A Study of the effects of research food intake on defecation and physical condition: single arm trial |
| Date of disclosure of the study information | 2023/10/14 |
| Last modified on | 2023/09/27 11:36:18 |
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Basic information
Public title
Study of the effects of research food intake on defecation and physical condition: single arm trial
Acronym
A Study of the effects of research food intake on defecation and physical condition
Scientific Title
A Study of the effects of research food intake on defecation and physical condition: single arm trial
Scientific Title:Acronym
A Study of the effects of research food intake on defecation and physical condition
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of the study foods on the defecation status and physical condition of males aged 20 years and older and under 65 years of age by having them consume the study foods for 3 days continuously.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation status
Physical status questionnaire
Fecal composition
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects take 0.5 g/kg body weight of the test food per dose for 3 days after dinner.
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
Key inclusion criteria
1.Those who are aged between 20 and 65 yeas at the time of informed consent.
2.Healthy Japanese males.
3.Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose, and made the written agreement.
4.Those who judged by the principal investigator to be safe to participate in the study based on the results of the screening test.
5.Those who have consumed test foods in amounts equivalent to the intervention in this study and have not experienced significant physical illness as a result of the intervention.
Key exclusion criteria
Subjects --
1.who are judged by the principal investigator to be ineligible to participate in this study with regard to their health condition.
2.with low metabolic capacity of the test food as a result of screening test.
3.body weight over 80 kg or BMI over 30.
4.allergic or intolerant to the test food.
5.with current or history of serious illnesses, especially those with complications or history of renal or hepatic disease.
6.judged by the principal investigator to be unsuitable for this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ozeki |
Organization
Taiyo Kagaku Co., Ltd
Division name
Nutrition Division
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichishi, Mie, Japan
TEL
059-347-5411
mozeki@taiyokagaku.co.jp
Public contact
Name of contact person
| 1st name | So |
| Middle name | |
| Last name | Morishima |
Organization
Taiyo Kagaku Co., Ltd
Division name
Nutrition Division
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichishi, Mie, Japan
TEL
059-347-5411
Homepage URL
smorishima@taiyokagaku.co.jp
Sponsor or person
Institute
Taiyo Kagaku Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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
Taiyo Kagaku Co., Ltd institutional review board
Address
1-3 Takaramachi, Yokkaichishi, Mie, Japan
Tel
059-347-5400
tnakamura@taiyokagaku.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
| 2023 | Year | 10 | Month | 14 | 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
| 2023 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 01 | 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
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059730
| 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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| Registered date | File name |
