UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043278 |
|---|---|
| Receipt number | R000049401 |
| Scientific Title | Effect of the combined ingestion of plant-derived ingredients on the pharmacokinetic parameter |
| Date of disclosure of the study information | 2021/02/08 |
| Last modified on | 2021/02/08 14:48:24 |
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Basic information
Public title
Effect of the combined ingestion of plant-derived ingredients on the pharmacokinetic parameter
Acronym
Effect of the combined ingestion of plant-derived ingredients on the pharmacokinetic parameter
Scientific Title
Effect of the combined ingestion of plant-derived ingredients on the pharmacokinetic parameter
Scientific Title:Acronym
Effect of the combined ingestion of plant-derived ingredients on the pharmacokinetic parameter
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dose-response effect of the ingredients on the pharmacokinetic parameter
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the pharmacokinetic parameter after the single ingestion.
(AUC)
Key secondary outcomes
Evaluation of the pharmacokinetic parameter after the single ingestion.
(Cmax, Tmax)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
control (1) > wash out > control (2) > wash out > test beverage (1) > wash out > test beverage (2) > wash out > test beverage (3)
Interventions/Control_2
control (2) > wash out > test beverage (2) > wash out > test beverage (3) > wash out > test beverage (1) > wash out > control (1)
Interventions/Control_3
test beverage (1) > wash out > test beverage (3) > wash out > control (2) > wash out > control (1) > wash out > test beverage (2)
Interventions/Control_4
test beverage (2) > wash out > test beverage (1) > wash out > control (1) > wash out > test beverage (3) > wash out > control (2)
Interventions/Control_5
test beverage (3) > wash out > control (1) > wash out > test beverage (2) > wash out > control (2) > test beverage (1)
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
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males
BMI <= 18.5 and >= 29.9
Key exclusion criteria
1) history of or under treatment for gastrointestinal disorder
2) under treatment for severe disease
3) taking therapeutic medicine
4) TG > 399mg/dL, T-Cho > 259mg/dL, FBG 125mg/dL > and HbA1c > 6.4%, AST > 50U/L, ALT > 50U/L, g-GTP > 100U/L
5) HBs positive, HCV positive
6) creatinine > 1.29mg/dL, BUN > 22.0mg/dL
7) syphilis positive, HIV positive
8) food allergy
9) shift worker
10) blood donor (> 200 mL within the last month or > 400 mL within the last 3 months)
11) heavy drinker
12) heavy smoker
13) drinking less than 2 cups of tea or coffee per day
14) Subjects who are judged to be inappropriate for the study by the medical doctor
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Hibi |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL
+81-3-5630-7266
hibi.masanobu@kao.com
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Oishi |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL
+81-3-5630-7266
Homepage URL
oishi.sachiko@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Japan Conference of Clinical Research
Address
2-27-17 Minami-ikebukuro, toshima-ku, Tokyo, 171-0022, Japan
Tel
03-6868-7022
kakigi@3h-ms.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
医療法人社団成守会 成守会クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 08 | 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
8
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
| 2016 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 23 | 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
| 2021 | Year | 02 | Month | 08 | Day |
Last modified on
| 2021 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049401
