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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042924
Receipt No. R000048999
Scientific Title Examination of the effects of Jerusalem artichoke inulin intake on gastrointestinal function and bowel movement improvement
Date of disclosure of the study information 2021/01/12
Last modified on 2021/10/07

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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 Co., Ltd
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 Co., Ltd
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 03-6704-5968
Email n-yuzawa@imeqrd.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 15
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
2020 Year 12 Month 11 Day
Date of IRB
2020 Year 12 Month 22 Day
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 10 Month 07 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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