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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031874
Receipt No. R000036284
Scientific Title Study on the effects of beverages on health(SIC-2017-14-CAFF)
Date of disclosure of the study information 2018/03/24
Last modified on 2018/09/27

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Basic information
Public title Study on the effects of beverages on health(SIC-2017-14-CAFF)
Acronym Study on the effects of beverages on health
Scientific Title Study on the effects of beverages on health(SIC-2017-14-CAFF)
Scientific Title:Acronym 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
1st name
Middle name
Last name Norihiko Kageyama
Organization Suntory Global Innovation Center Ltd.
Division name Research Institute
Zip code
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
1st name
Middle name
Last name Yoko Kamada
Organization Suntory Global Innovation Center Ltd.
Division name Research Institute
Zip code
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)

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
2018 Year 03 Month 24 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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 23 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000036284

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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