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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031868
Receipt No. R000036389
Scientific Title Exploratory test on the influence of pineapple intake on improvement in intestinal bacterial flora
Date of disclosure of the study information 2018/03/23
Last modified on 2018/04/16

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Basic information
Public title Exploratory test on the influence of pineapple intake on improvement in intestinal bacterial flora
Acronym Exploratory test on the influence of pineapple intake on improvement in intestinal bacterial flora
Scientific Title Exploratory test on the influence of pineapple intake on improvement in intestinal bacterial flora
Scientific Title:Acronym Exploratory test on the influence of pineapple intake on improvement in intestinal bacterial flora
Region
Japan

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

Objectives
Narrative objectives1 Explore the effect of pineapple intake on improvement in intestinal bacterial flora.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intestinal bacterial flora at the beginning of the test or after ingestion of four weeks
Key secondary outcomes General blood biochemical test (total protein, albumin, total cholesterol, blood neutral fat (TG), HDL-cholesterol, LDL-cholesterol, AST(GOT), ALT(GPT), ALP, gamma-GTP, CPK, total bilirubin, uric acid, urea nitrogen, creatinine, sodium, potassium, chlorine, calcium, phosphorus, LDH, HbA1c, glucose), urine test (8-OHdG, creatinine, presumptive salt intake, Na / K ratio, indoxyl sulfate), physical examination (body weight, blood pressure, pulse rate, BMI), and questionnaire at the beginning of the test or after ingestion of 4 weeks

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingest total 100 g of pineapple per day.
Interventions/Control_2 None
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
64 years-old >=
Gender Female
Key inclusion criteria 1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese women who are 20 years old or more and under 64 years old
3.Persons whose frequency of defecation is 2~4 times per week during the two weeks before the onset of screening
Key exclusion criteria 1.Persons who have a chronic disease and is under medication, or has a serious disease history
2.Persons who are allergic to the test food
3.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement
4.Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period
5.Persons who are judged inappropriate for the exam by the principal investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohito Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development
Zip code
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 0368092722
Email ishikawa@hc-sys.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohito Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development
Zip code
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 0368092722
Homepage URL
Email ishikawa@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization SOLROS Co., Ltd.
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
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 23 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 Completed
Date of protocol fixation
2018 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 18 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 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036389

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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