UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050544 |
|---|---|
| Receipt number | R000057563 |
| Scientific Title | A Study of the effects of a test-food on defecation |
| Date of disclosure of the study information | 2023/03/12 |
| Last modified on | 2023/09/08 10:20:49 |
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Basic information
Public title
A Study of the effects of a test-food on defecation
Acronym
A Study of the effects of a test-food on defecation
Scientific Title
A Study of the effects of a test-food on defecation
Scientific Title:Acronym
A Study of the effects of a test-food on defecation
Region
| Japan |
Condition
Condition
Healthy men/female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to validate some kind of effect by the test-food intakes for four weeks on defecation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation status (the number of days, frequency, quantity, property, color, fecal odor, feeling of incomplete evacuation, abdominal swelling)
Key secondary outcomes
Physical condition(amount of food,sleep,skin,feeling,joint pain,cold hands and feet,swelling)
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
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test food (10 capsules a day) with water to the subjects for 4 weeks.
Interventions/Control_2
Ingestion of the placebo food (10 capsules a day) with water to the subjects for 4 weeks.
Interventions/Control_3
Ingestion of the placebo food (10 capsules a day) with water to the subjects for 4 weeks.
Interventions/Control_4
Ingestion of the placebo food (10 capsules a day) with water to the subjects for 4 weeks.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female subjects ranging in age from 50 to 100, at informed consent.
(2)Persons who have received a full explanation of the study, understand its contents, and have given their written consent.
(3)A person who understands the consent statement and obtains his/her signature
Key exclusion criteria
(1)Those who are currently receiving medication or outpatient treatment for various diseases that interfere with their daily life.
(2)Those who are currently on a strict exercising or dieting under the supervision of a doctor
(3)Subjects who may develop food allergies due to the test food
(4)Those who have a current or a history of drug dependence or alcohol dependence
(5)Those who are undergoing hospital visits for mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.), or have a history of mental illness in the past
(6)Subjects with significantly irregular life rhythms (eating, sleeping, extremely unbalanced diet, etc.)
(7)Persons using drugs that affect immune function
(8)Those who participated in other clinical trials (research) within 3 months before the date of consent acquisition, or those who plan to participate in other clinical trials (research) during the trial period
(9)Those who are at risk of aspiration
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Kudo |
Organization
Komazawa Women's University
Division name
Faculty of Human Health Depertment of Health and Nutrition Sciences
Zip code
206-8511
Address
238 Sakahama, Inagi-shi Tokyo
TEL
042-350-7111
m-kudoh@komajo.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Ohashi |
Organization
Ebara Foods industry,Inc.
Division name
Creative Division Research Institute
Zip code
258-0015
Address
1408 Yamada,Oimachi,Ashigarakamigun,Kanagawa 258-0015,Japan
TEL
0465-85-5181
Homepage URL
a.oohashi@ebarafoods.co.jp
Sponsor or person
Institute
Komazawa Women's University
Institute
Department
Personal name
Funding Source
Organization
Ebara Foods industry,Inc.
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
Komazawa Women's University Institutional Review Board
Address
238 Sakahama, Inagi-shi Tokyo
Tel
042-350-7111
suishin-c@komajo.ac.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
| 2023 | Year | 03 | 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
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
| 2022 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057563
