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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
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 | 2021/01/06 |
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 |
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Condition | ||
Condition | Healthy adults | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 15 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |