UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042720 |
|---|---|
| Receipt number | R000048757 |
| Scientific Title | A study to compare the absorbency after test food intake. |
| Date of disclosure of the study information | 2020/12/12 |
| Last modified on | 2021/05/06 09:14:25 |
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Basic information
Public title
A study to compare the absorbency after test food intake.
Acronym
A study to compare the absorbency after test food intake.
Scientific Title
A study to compare the absorbency after test food intake.
Scientific Title:Acronym
A study to compare the absorbency after test food intake.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the absorbability of three types of test foods.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC
Cmax
Key secondary outcomes
Tmax
T1/2
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake of food A and placebo-Wash out-Single intake of food B-Wash out-Single intake of food C and placebo
Interventions/Control_2
Single intake of food B-Wash out-Single intake of food C and placebo-Wash out-Single intake of food A and placebo
Interventions/Control_3
Single intake of food C and placebo-Wash out-Single intake of food A and placebo-Wash out-Single intake of food B
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 and Female
Key inclusion criteria
1)Japanese healthy males and females aged from 20 to 59 years old
2)Subjects who can visit the medical institution where the test is conducted on the scheduled visit date and can be hospitalized for 2 nights and 3 days in this test
3)Subjects who have an ability to understand the purpose and contents of this clinical trial and voluntarily
applied and agreed to participate in
this clinical trial after the explanation
of this clinical trial
Key exclusion criteria
1)Subjects who regularly use foods containing the ingredients used in this test
2)Subjects who usually intake a food for specified health use, functional food and health foods
3)Subjects who weigh 40 kg or less or 100 kg or more, or who have a BMI of 31 or more
4)Subjects who are under treatment or have a history of serious heart disease, lung disease, gastrointestinal disease, hypertension, diabetes, or malignant neoplasms
5)Subjects who usually intake drug
6)Subjects who are pregnant, lactation, or planning to become pregnant
7)Subjects who are sensitive to test product or other foods, and medical products
8)Subjects who have collected more than 200 mL of blood 4 weeks before
the Screening test or 400 mL of blood before 16 weeks before the Screening test
9)Subjects who have had a bad mood or poor physical condition due to blood sampling in the past
10)Subjects who participated in other clinical studies
11)Subjects who are judged as unsuitable for this study by the principal investigator for other reasons
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kazumoto |
| Middle name | |
| Last name | Sasaki |
Organization
Medical Corporation Ichigenkai
Division name
Sasaki Memorial Hospital
Zip code
359-1144
Address
1-7-25, Nishitokorozawa, Tokorozawa Shi, Saitama Ken, Japan
TEL
04-2923-1123
soumuka@sasaki-memorial.com
Public contact
Name of contact person
| 1st name | Fukuko |
| Middle name | |
| Last name | Kubota |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Department Clinical Operations Division
Zip code
103-0027
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo, JAPAN
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
THERAVALUES 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
Kanazawabunko Hospital IRB
Address
2-6-22,Kamariyahigashi,Kanazawa-ku,Yokohama-shi,Kanagawa-ken,Japan
Tel
045-785-3311
h.itou@kanabun-hp.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
| 2020 | Year | 12 | Month | 12 | 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
24
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
| 2020 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 01 | 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
| 2020 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048757
