UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the effects of beverages on health(SIC-2017-14-CAFF)
Title of the study (Brief title)	Study on the effects of beverages on health
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate effects of beverages on health
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood pressure, Heart rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of test food 1 -> Washout (5 days or more) -> Single ingestion of test food 2 -> Washout (5 days or more) -> Single ingestion of test food 3-> Washout (5 days or more) -> Single ingestion of test food 4.
Interventions/Control_2	Single ingestion of test food 2 -> Washout (5 days or more) -> Single ingestion of test food 1 -> Washout (5 days or more) -> Single ingestion of test food 4 -> Washout (5 days or more) -> Single ingestion of test food 3.
Interventions/Control_3	Single ingestion of test food 3 -> Washout (5 days or more) -> Single ingestion of test food 4 -> Washout (5 days or more) -> Single ingestion of test food 1 -> Washout (5 days or more) -> Single ingestion of test food 2.
Interventions/Control_4	Single ingestion of test food 4 -> Washout (5 days or more) -> Single ingestion of test food 3 -> Washout (5 days or more) -> Single ingestion of test food 2 -> Washout (5 days or more) -> Single ingestion of test food 1.
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	55 years-old >=
Gender	Male
Key inclusion criteria	(1)Males whose age are 20 <= years old <= 55. (2)Subjects who agree to participate this study before screening test, and are able to submit the written informed consents. (3)Subjects who do not smoke in 6 months before the screening test. (4)Subjects whose body mass index at the screening test are 18.5 <= kg/m2 < 30.0.
Key exclusion criteria	(1)Subjects who are with treatment. (2)Subjects who are with history of gastrointestinal surgery. (3)Subjects who are participating in other human study or finished to participate in human study within 4week. (4) Subjects are as below: a)Subjects with any disease in heart, liver, kidney (complications of other disease) b)Subjects with medical history of cardiovascular diseases (c)Subjects who develop diabetes (by diagnosis standard of Japanese Society of Diabetes) (d)Subjects who develop allergy to the test foods. (5) Alcohol polydipsia's (6)Subjects whose eating habits are extremely irregular. (7)Subjects whose results of screening test are not negative in syphilis, HCV antibody, HIV antigen and HIV antibody. (8)Subjects who are deemed to be unsuitable by the investigator.
Target sample size	32

Research contact person
Name of lead principal investigator	Norihiko Kageyama
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL	050-3182-0823
Email	Norihiko_Kageyama@suntory.co.jp

Public contact
Name of contact person	Yoko Kamada
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL	050-3182-0360
Homepage URL
Email	Yoko_Kamada@suntory.co.jp

Sponsor
Institute	Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 03 Month 24 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 03 Month 23 Day
Anticipated trial start date	2018 Year 03 Month 24 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	2018 Year 03 Month 23 Day
Last modified on	2018 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036284