UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032670 |
|---|---|
| Receipt number | R000037254 |
| Scientific Title | A study for evaluating the safety of the intake of a test food for healthy adults. |
| Date of disclosure of the study information | 2018/05/28 |
| Last modified on | 2018/10/29 13:43:13 |
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Basic information
Public title
A study for evaluating the safety of the intake of a test food for healthy adults.
Acronym
A study for evaluating the safety of the intake of a test food.
Scientific Title
A study for evaluating the safety of the intake of a test food for healthy adults.
Scientific Title:Acronym
A study for evaluating the safety of the intake of a test food.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive (19.5 g ; three times the estimated amount of daily intake) ingestion of a test food for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight
Doctor's questions
Adverse event
Stool output, defecation frequency, defecation days, fecal condition
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
Ingestion of a test food for 4 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
(1) Healthy males and females aged 20-64 years.
(2) Subjects with a tendency for constipation at around three to five times of defecation per week.
Key exclusion criteria
(1) Subjects who routinely use food rich in dietary fiber.
(2) Subjects routinely taking medicine or health food which may influence bowel movement.
(3) Subjects having a large amount of foods which may influence bowel movement such as food containing dietary fiber and lactic acid bacteria.
(4) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative.
(5) Subjects having diseases or a history of drug addiction or alcoholism.
(6) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease).
(7) Subjects having possibilities for emerging allergy related to the study.
(8) Subjects who are under medication or having a history of serious diseases for which medication was required.
(9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(10) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study.
(11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(13) Subjects judged as unsuitable for the study by the investigator for other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Takagi |
Organization
NIHON SHOKUHIN KAKO CO., LTD.
Division name
RESEARCH INSTITUTE
Zip code
Address
30 TAJIMA FUJI, SHIZUOKA
TEL
0545-53-5995
hiroki.takagi@nisshoku.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Yamamichi |
Organization
TTC Co.,Ltd
Division name
Clinical Research Planning Department
Zip code
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
s.yamamichi@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
NIHON SHOKUHIN KAKO 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
Address
Tel
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
| 2018 | Year | 05 | Month | 28 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 22 | Day |
Last modified on
| 2018 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037254
