UMIN-CTR Clinical Trial

Basic information
Public title	The pilot study of effects of food containing plant constituents.
Acronym	The pilot study of effects of food containing plant constituents.
Scientific Title	The pilot study of effects of food containing plant constituents.
Scientific Title:Acronym	The pilot study of effects of food containing plant constituents.
Region	Japan

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

Objectives
Narrative objectives1	In order to investigate the effect of food containing plant constituents in adults who have constipation tendency.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intestinal microflora
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Food containing plant constituents, feeding three times a day for 4 weeks in term1. Placebo food not containing plant constituents, feeding three times a day for 4 weeks in term2.
Interventions/Control_2	Placebo food not containing plant constituents, feeding three times a day for 4 weeks in term1. Food containing plant constituents, feeding three times a day for 4 weeks in term2.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Healthy males aged 20 or more. 2)Subjects whose defecate between 3 to 5 times in a week in a week. 3)Subjects who don't take constantly use supplements and/or functional foods (including Food for Specified Health Uses and Foods with Function Claims) affecting the intestinal regulation, cholesterol, serum triglyceride, body fat. 4)Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	1) Subjects whose systolic blood pressure is less than 90 mmHg. 2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 3) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study. 4) Males whose blood was collected more than 400 mL within the last twelve weeks. 5) Females whose blood was collected more than 400 mL within the last twelve weeks. 6) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks. 7) Subject who are applicable to one of the below. a) Subject who are contracting heart, liver or kidney disease including the case of complicating disease. b) Subjects with a previous history of cardiovascular disease. c) Subjects who are contracting diabetes. d) Subjects who have allergy to test food. 8) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. 9) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. 10) Subjects who underwent abdominal surgical operation within 6 month before test start. 11) Subjects who took antibiotics for 1 month or more within 6 month before test start. 12) Subjects who have an irregular sleep cycle, work shift or work on midnight shift. 13) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses, Foods with Function Claims). 14) Subjects who plan big change of lifestyle during test period. 15) Subjects with tendency of chronic diarrhea. 16) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart. 17) Subjects who suspected chronic or acute infectious disease.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Norihito Murayama
Organization	Suntory Global Innovation Center Ltd.
Division name	Innovation Development Department
Zip code
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL	050-3182-0588
Email	Norihito_Murayama@suntory.co.jp

Public contact
Name of contact person	1st name Middle name Last name Kenichi Wakabayashi
Organization	Suntory Global Innovation Center Ltd.
Division name	Innovation Development Department
Zip code
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL	050-3182-0599
Homepage URL
Email	Kenichi_Wakabayashi@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	Japan

Other related organizations
Co-sponsor	MetaGen, Inc.
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	チヨダパラメディカルケアクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 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	2016 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date	2016 Year 04 Month 04 Day
Last follow-up date	2016 Year 08 Month 10 Day
Date of closure to data entry	2016 Year 12 Month 15 Day
Date trial data considered complete	2016 Year 12 Month 30 Day
Date analysis concluded	2017 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 03 Month 29 Day
Last modified on	2016 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024983

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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