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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028728
Receipt No. 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

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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
Email 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
Email s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032878

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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