UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045361 |
|---|---|
| Receipt number | R000051797 |
| Scientific Title | A study for evaluating the safety of the intake of a test food. |
| Date of disclosure of the study information | 2022/12/21 |
| Last modified on | 2023/01/17 17:24:41 |
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Basic information
Public title
A study for evaluating the safety of the intake of a test food.
Acronym
A study for evaluating the safety of the intake of a test food.
Scientific Title
A study for evaluating the safety of the intake of a test food.
Scientific Title:Acronym
A study for evaluating the safety of the intake of a test food.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The bowel movements and safety of test food after 4 consecutive weeks of ingestion will be examined using placebo as a control.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/body mass index
Bowel movement status (frequency of bowel movements, number of days of bowel movements, volume of bowel movements, stool characteristics)
Adverse event
Evaluate at points of 2 week and 4 week of intake and 2 weeks after the end of ingestion period
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take one bag of the test food once a day for 4 weeks.
Interventions/Control_2
Take one bag of the placebo once 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Men and women between 20 and 64 years of age.
(2) Healthy persons who defecated 6 or more times per week during the previous observation period and had diarrhea or soft stools (Bristol stool scale 6 or 7) less than once per week (24 persons)
(3) Persons prone to constipation who defecated 3-5 times a week in the previous observation period and had diarrhea or soft stools (Bristol stool scale 6 and 7) less than once a week (12 persons)
(4) Those who defecated more than 3 times a week and had diarrhea or soft stool (Bristol stool scale 6 or 7) more than once a week in the previous observation period (12 persons)
Key exclusion criteria
(1) Those who regularly use foods (including foods for specified health uses) that contain a lot of dietary fiber materials (indigestible dextrin, polydextrose, indigestible glucan, etc.)
(2) Those who regularly use medicines, health foods, foods for specified health uses, or functional foods that may affect bowel movements.
(3) Those who are in the habit of consuming a large amount of foods that are thought to affect bowel movements (foods rich in dietary fiber and lactic acid bacteria)
(4) Persons who are visiting a hospital and using medication for a bowel movement-related disease or who are regularly using over-the-counter laxatives at the time of research participation.
(5) Those with a history or current condition of drug or alcohol dependence.
(6) Persons with serious diseases such as diabetes, liver disease, renal disease, cardiac disease, or those with pre-existing diseases.
(7) Persons at risk of developing allergies related to the research.
(8) Those with a disease under treatment or with a history of serious disease that required medication.
(9) Persons whose anthropometric, physical, and clinical values are significantly out of the reference range before the start of intake.
(10) Those who have participated in other clinical research within one month prior to obtaining consent to participate in this study, or those who plan to participate in other clinical research after obtaining consent to participate in this.
(11) Those who are pregnant or plan to become pregnant or breastfeed during the study period.
(12) Those who are judged to be unsuitable as subjects based on the answers to the lifestyle questionnaire.
(13) Any other person who is judged as inappropriate as a subject by the Chief Medical Officer.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Takagi |
Organization
NIHON SHOKUHIN KAKO CO., LTD.
Division name
RESEARCH INSTITUTE
Zip code
417-8530
Address
30 TAJIMA FUJI, SHIZUOKA
TEL
0545-53-5995
hiroki.takagi@nisshoku.co.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
Organization
EP Mediate Co., Ltd.
Division name
Development Business Headquarters, TTC Center, Trial Planning Department
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
090-4821-1099
Homepage URL
yamamichi.shingo578@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NIHON SHOKUHIN KAKO 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
saito.teruo876@eps.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
| 2022 | Year | 12 | Month | 21 | 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
| 2021 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2021 | Year | 09 | Month | 03 | Day |
Last modified on
| 2023 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051797
