UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042924 |
|---|---|
| Receipt number | 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 10:15:38 |
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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
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
y-hira@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048999
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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