UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of blood kinetics at the time of ingestion of food containing Santa Berry extract in three different forms
Title of the study (Brief title)	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	Tetsuya Sogon
Organization	WAKASA SEIKATSU Co., Ltd.
Division name	R&D department
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	Shinsuke Tsuji
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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