UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036325 |
|---|---|
| Receipt number | R000040684 |
| Scientific Title | Effects of a Test Food for Defecation Improvement. |
| Date of disclosure of the study information | 2019/03/28 |
| Last modified on | 2019/09/17 17:31:27 |
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Basic information
Public title
Effects of a Test Food for Defecation Improvement.
Acronym
Effects of a Test Food for Defecation Improvement.
Scientific Title
Effects of a Test Food for Defecation Improvement.
Scientific Title:Acronym
Effects of a Test Food for Defecation Improvement.
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate effects of a test food for defecation improvement and its safety(a randomized, double-blind, placebo-controlled, parallel-group study).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Indexes for evaluating defecation (The Japanese Version of the Constipation Assessment Scale (1), Patient Assessment of Constipation of Quality Of Life scale (1), Bristol stool scale (1), bowel diary (2)).
(1):Screening, Week 0, Week 2, Week 4.
(2):From the first day of ingestion of a test material to the last day of the test.
Key secondary outcomes
*Safety
[1]Blood pressure, pulsation (Screening, Week 0, Week 4).
[2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4).
[3]Doctor's questions (Screening, Week 0, Week 4).
[4]Subject's diary (each day during the test period).
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test product (4 capsules in a day for 4 weeks)
Interventions/Control_2
Oral intake of the placebo product (4 capsules in a day for 4 weeks)
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Healthy Japanese males and females aged 20-59 years.
[2]Individuals who are healthy and have no chronic physical disease.
[3]Individuals with a tendency for constipation (at 3-5 times of defecation per week); whose stool shape is relatively hard and who have unpleasant sensation on defecation.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can have an examination on a designated check day.
[6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1]Individuals using medical products.
[2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3]Individuals whose stool frequency is less than 3 times per week.
[4]Individuals who are constipated because of intaking internal medicine.
[5]Individuals who have idiopathic constipation.
[6]Individuals whose eating habits are irregular.
[7]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[9]Individuals who are a patient or have a history of or endocrine disease.
[10]Individuals whose BMI is over 30.
[11]Individuals who are sensitive to a test product or other foods, and medical products.
[12]Individuals who intake laxatives, antiflatulent etc. aiming to improve bowel movements.
[13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[14]Individuals with possible changes of life style, such as working a night shift, during the test period.
[15]Individuals who are or are possibly, or are lactating.
[16]Individuals who participated in other clinical studies in the past 3 months.
[17]Individuals who are or whose family is engaged in functional foods or cosmetics.
[18]Individuals judged inappropriate for the study by the principal.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshifumi |
| Middle name | |
| Last name | Okusa |
Organization
Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch
Division name
Head of Center
Zip code
110-0005
Address
1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN
TEL
+81-3-5816-0711
info@tes-h.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-601-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
i.takahashi@tes-h.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
| 2019 | Year | 03 | Month | 28 | 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
60
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
| 2019 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 07 | 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 | 03 | Month | 28 | Day |
Last modified on
| 2019 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040684
