UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effects of Jerusalem artichoke inulin intake on gastrointestinal function and bowel movement improvement
Acronym	Examination of the effects of Jerusalem artichoke inulin intake on gastrointestinal function and bowel movement improvement
Scientific Title	Examination of the effects of Jerusalem artichoke inulin intake on gastrointestinal function and bowel movement improvement
Scientific Title:Acronym	Examination of the effects of Jerusalem artichoke inulin intake on gastrointestinal function and bowel movement improvement
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of ingesting different dose test foods for 2 weeks each for men and women with constipation tendency, and to examine the dose dependence.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation survey (frequency of defecations)
Key secondary outcomes	Defecation survey (defecation volume, fecal properties by Bristol score and abdominal symptoms etc.), intestinal flora (by T-RFLP)

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Dissolve 1 bag (high content) in drinks and take before breakfast daily.
Interventions/Control_2	Dissolve 1 bag (low content) in drinks and take before breakfast daily.
Interventions/Control_3	Dissolve 1 bag (placebo) in drinks and take before breakfast daily.
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	Male and Female
Key inclusion criteria	1. Aged 20 to under 64 at the time of informed consent 2. Japanese men and women 3. Subjects who deficate 2 to 5 times a week 4. Subjects who can input electronic diary with smartphone / PC 5. Subjects who understand the contents of the trial and obtain written consent before the trial based on the person's free will
Key exclusion criteria	Subjects who 1. are currently receiving any types of medicines and/or Chinese medical treatment (except for the drugs taken as needed). 2. are on a diet or exercise therapy under the supervision of a doctor. 3. have a current or history of serious illness. 4. are undergoing treatment for digestive disorders and constipation. 5. have had gastrointestinal surgery (appendicitis is acceptable). 6. take antiflatulent or laxatives daily. 7. take lactic acid bacteria drinks, yogurt or supplements containing lactic acid bacteria daily. 8. take foods for specified health use and foods with functional claims daily. 9. have a past and current medical history of drug or food allergy. 10. have participated in other clinical trials within one month before obtaining consent, or those who plan to participate during the trial period. 11. are currently pregnant or breastfeeding or those who want to become pregnant during the study period. 12. consume alcohol excessively (alcohol equivalent 60g or more / day). 13. have smoking habit. 14. have irregular life rhythms (work in shifts, work late at night etc.). 15. are judged by the investigator to be unsuitable for participating in this study.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Hiramatsu
Organization	Melodian CO.,LTD.
Division name	Research & development division
Zip code	581-0869
Address	2-128-1 sakuragaoka, Yao-Shi, Osaka
TEL	072-924-3215
Email	naohiramatsu@melodian.co.jp

Public contact
Name of contact person	1st name Yoshitada Middle name Last name Hira
Organization	IMEQRD inc.
Division name	Sales department
Zip code	104-0061
Address	6-2-1 Ginza Chuo-ku Tokyo
TEL	03-6704-5968
Homepage URL
Email	y-hira@imeqrd.co.jp

Sponsor
Institute	IMEQRD inc.
Institute
Department

Funding Source
Organization	Melodian CO.,LTD.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Suda Clinic institutional review board
Address	2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel	03-3207-8161
Email	suda-clinic_irb@imeq.co.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

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 12 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	Preinitiation
Date of protocol fixation	2020 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date	2021 Year 01 Month 13 Day
Last follow-up date	2021 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 01 Month 06 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048999

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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