UMIN-CTR Clinical Trial

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

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To evaluate effects of beverages on health

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Blood pressure, Heart rate

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Suntory Global Innovation Center Ltd.

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

03

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

03

Month

23

Day

Last modified on

2018

Year

09

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036284