UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory test on the influence of pineapple intake on improvement in intestinal bacterial flora
Title of the study (Brief title)	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	Hirohito Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
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	Hirohito Ishikawa
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 10 Day
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

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 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