UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028728 |
|---|---|
| Receipt number | R000032878 |
| Scientific Title | Investigation of blood kinetics at the time of ingestion of food containing Santa Berry extract in three different forms |
| Date of disclosure of the study information | 2017/08/18 |
| Last modified on | 2017/09/23 12:16:13 |
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Basic information
Public title
Investigation of blood kinetics at the time of ingestion of food containing Santa Berry extract in three different forms
Acronym
Investigation of blood kinetics at the time of ingestion of food containing Santa Berry extract in three different forms
Scientific Title
Investigation of blood kinetics at the time of ingestion of food containing Santa Berry extract in three different forms
Scientific Title:Acronym
Investigation of blood kinetics at the time of ingestion of food containing Santa Berry extract in three different forms
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Obtain knowledge of the influence of Santa Berry-derived resveratrol-containing food in different forms on blood kinetics
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood concentration of resveratrol
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest a hard capsule containing resveratrol from Santa Berry
Interventions/Control_2
Ingest an orally disintegrating tablet containing resveratrol from Santa Berry
Interventions/Control_3
Ingest a beverage containing resveratrol from Santa Berry
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females from 20 to 50 years of age
Key exclusion criteria
(1) Subjects who routinely use health food containing participating component
(2) Subjects with female hormone sensitive diseases such as endometriosis and those who have an existing medical history
(3) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(4) Subjects having possibilities for emerging allergy related to the current study
(5) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(6) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination
(7) Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study
(8) Subjects who intend to become pregnant or lactating
(9) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire
(10) Subjects judged as unsuitable for the current study by the investigator
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Sogon |
Organization
WAKASA SEIKATSU Co., Ltd.
Division name
R&D department
Zip code
Address
Sagawa Global Logistics 5 Minaminekoya-cho Fushimi-ku Kyoto 612-8379 JAPAN
TEL
075-604-6776
sogon@blueberryeye.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Tsuji |
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.tsuji@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
WAKASA SEIKATSU 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
| 2017 | Year | 08 | Month | 18 | 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
| 2017 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 21 | 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
| 2017 | Year | 08 | Month | 18 | Day |
Last modified on
| 2017 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032878
