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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035881
Receipt No. R000040881
Scientific Title Effect of the test food on breath hydrogen excretion -A randomized, open-label, cross over study-
Date of disclosure of the study information 2019/02/15
Last modified on 2019/08/19

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Basic information
Public title Effect of the test food on breath hydrogen excretion
-A randomized, open-label, cross over study-
Acronym Effect of the test food on breath hydrogen excretion
Scientific Title Effect of the test food on breath hydrogen excretion
-A randomized, open-label, cross over study-
Scientific Title:Acronym Effect of the test food on breath hydrogen excretion
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the test food on breath hydrogen excretion
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Breath hydrogen excretion(AUC 0-8h)
Key secondary outcomes Breath hydrogen excretion(The observed values and the change from pre-intake of breath hydrogen excretion at each evaluation point)

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 No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single intake of test food- single intake of control food
Interventions/Control_2 Single intake of control food- single intake of test food
Interventions/Control_3
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1)Male and Female aged from 20 to 65 years old at the time of informed consent is taken
2)Subjects whose BMI below 25 at the screening test
3)Subjects who eat 3 times a day
4)Subjects who agree to participate in the study on one's own will
Key exclusion criteria 1)Subjects who are suffering from disease affect gastric emptying and digestion function
2)Subjects who have a surgical history of the digestive organs
3)Subjects who have a disease such as upper respiratory inflammation and acute gastroenteritis
4)Subjects who defecate 3 times or above per day
5)Subjects who defecate less than 3 times per week
6)Subjects who are suffering from indigestion symptoms
7)Subjects who have a habit of excessive alcohol
8)Subjects who smoke daily
9)Subjects who had taken antibiotics and/or anti-microbe a gents within 1 month prior to date of the informed consent, or who is going to taking them during study
10)Subjects who taking medicine that may affect the examination and subjects who eat daily brown rice, cereals etc
11)Subjects who take health food (a probiotic dairy product etc) excessively that may affect the examination
12)Subjects who is allergic to rice
13)Subjects who are pregnant or breast-feeding, or subjects who expect to be pregnant during this study
14)Subjects who participating in other clinical studies, or who are planning to participate in other clinical studies during the present study
15)Subjects whose fasting breath methane concentration is 10 ppm or above at the screening test
16)Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kei
Middle name
Last name Yui
Organization FANCL Corporation
Division name Research Institute, Health science research center
Zip code 244-0806
Address 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL 045-820-3755
Email ke-yui@fancl.co.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address Shibaura Omodaka Building7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization FANCL Corporation
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 Ethical Committee of Nihonbashi Cardiology Clinic
Address Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel 03-5641-4133
Email niho-jimucho@well-sleep.jp

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 日本橋循環器科クリニック(東京都) Nihonbashi Cardiology Clinic(Tokyo)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 15 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 20
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
2019 Year 02 Month 08 Day
Date of IRB
2019 Year 02 Month 08 Day
Anticipated trial start date
2019 Year 02 Month 17 Day
Last follow-up date
2019 Year 03 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 15 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040881

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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