UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035613 |
|---|---|
| Receipt number | R000040573 |
| Scientific Title | Effects of consumption of the test food on bowel movement and intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2019/01/21 |
| Last modified on | 2021/05/27 11:02:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of consumption of the test food on bowel movement and intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
Effects of consumption of the test food on bowel movement and intestinal environment
Scientific Title
Effects of consumption of the test food on bowel movement and intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Effects of consumption of the test food on bowel movement and intestinal environment
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of the test food on bowel movement and intestinal environment on the healthy Japanese adult subjects who defecate three to five times per week and do not eat enough fiber
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Defecation frequency
*1 Record the bowel movement diary from a week before screening (before consumption) to the day before screening (before consumption) and from a week before consuming to the day before 4 weeks after consuming (total 3 weeks)
Key secondary outcomes
1. Defecation days
2. Amount of defecation
3. Shape of stool
4. Smell of stool
5. Exhilarating feeling
6. Bifidobacterium
7. Lactobacillales
8. Bacteroides
9. Prevotella
10. Clostridium cluster IV
11. Clostridium cluster IX
12. Clostridium cluster XI
13. Clostridium subcluster XIVa
14. Clostridium cluster XVIII
15. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
16. Bristol stool scale
17. Succinic acid
18. Lactic acid
19. Formic acid
20. Acetic acid
21. Propionic acid
22. iso-Butyric acid
23. n-Butyric acid
24. iso-Valeric acid
25. n-Valeric acid
*1-5 Record the bowel movement diary from a week before screening (before consumption) to the day before screening (before consumption) and from a week before consuming to the day before 4 weeks after consuming (total 3 weeks)
*6-25 Assess the measured values or the amount of change at screening (before consumption) and at 2 weeks after consumption
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 2 weeks
Test food: Tablets containing mulukhiya
Administration: Take a total of 30 tablets per day between meals with water and no chewing
Interventions/Control_2
Duration: 2 weeks
Test food: Placebo tablets
Administration: Take a total of 30 tablets per day between meals with water and no chewing
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 subjects
2. Japanese adult subjects
3. Subjects who defecate three to five times per week
4. Subjects who do not eat enough fiber in usual dietary life
5. Subjects who are determined as eligible to participate in the study by the physician
6. Subjects who have relatively a few defecation frequencies at a week before screening (before consumption)
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements
6. Subjects who regularly use anticoagulants, such as warfarin
7. Subjects who are allergic to medicines and/or the test food related products
8. Subjects who are pregnant, breast-feeding, or planning to become pregnant
9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are ineligibility to participate in the study based on the evaluation of the physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
AOTSUBU CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
info@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Published
Result
URL related to results and publications
https://ffhdj.com/index.php/ffhd/article/view/686
Number of participants that the trial has enrolled
22
Results
Nagahara H, Nagahara M, Ohmi N, Takahashi Y, Takara T. Bowel movement improvement by Mulukhiyah (Corchorus olitorius)-containing food (AOTSUBU) consumption: A randomized, double-blind, placebo-controlled, parallel-group comparison trial. FFHD 2020; 10(5): 210-227
Results date posted
| 2021 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 03 | Month | 18 | Day |
Baseline Characteristics
Refer to the paper
Participant flow
Refer to the paper
Adverse events
Refer to the paper
Outcome measures
Refer to the paper
Plan to share IPD
Undecided
IPD sharing Plan description
To require consultation among related companies
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 21 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040573
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
