UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034132 |
|---|---|
| Receipt number | R000038912 |
| Scientific Title | A study to compare the absorbency after food intake containing plant extract for adult males (1) |
| Date of disclosure of the study information | 2019/09/15 |
| Last modified on | 2018/12/13 16:33:42 |
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Basic information
Public title
A study to compare the absorbency after food intake containing plant extract for adult males (1)
Acronym
A study to compare the absorbency after food intake containing plant extract (1)
Scientific Title
A study to compare the absorbency after food intake containing plant extract for adult males (1)
Scientific Title:Acronym
A study to compare the absorbency after food intake containing plant extract (1)
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the absorbency of two types of plant extract containing food for healthy adult males
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC
Cmax
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of test food A- single intake of test food B
Interventions/Control_2
Single intake of test food B- single intake of test food A
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males aged 20-60 years
Key exclusion criteria
(1) Subjects having possibilities for emerging allergy related to the study.
(2) Subjects who are under medication.
(3) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease).
(4) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(5) Subjects who constantly take in supplement richly containing licorice extract.
(6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination at the screening.
(7) Subjects who have habits affecting research results, such as doing shift work day and night, or Subjects who have a plan that affect research results such as day and night shift work or going overseas.
(8) Subjects who have participated in other clinical study within the last one month prior to the current study.
(9) Subjects who are difficult to take the test food as instructed.
(10) Subjects who donated over 200 ml of blood at least one month before the test started.
(11) Subjects who have experience of bad mood or deteriorating physical condition due to blood collection.
(12) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yo Miyakoshi |
Organization
KANEKA CORPORATION
Division name
Pharma & Supplemental Nutrition Solutions Vehicle
Zip code
Address
1-12-32, Akasaka, Minato-ku, Tokyo
TEL
050-3133-9895
Yo.Miyakoshi@kaneka.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
KANEKA CORPORATION
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
| 2019 | Year | 09 | Month | 15 | 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 | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 18 | 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 | 09 | Month | 14 | Day |
Last modified on
| 2018 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038912
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
