UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045324 |
|---|---|
| Receipt number | R000051762 |
| Scientific Title | Placebo-controlled, double-blind, randomized, parallel-group comparative study of the effect of ingestion of test food on improving the intestinal environment |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2022/08/31 09:07:25 |
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Basic information
Public title
Placebo-controlled, double-blind, randomized, parallel-group comparative study of the effect of ingestion of test food on improving the intestinal environment
Acronym
Study of the effect of ingestion of test food on improving the intestinal environment
Scientific Title
Placebo-controlled, double-blind, randomized, parallel-group comparative study of the effect of ingestion of test food on improving the intestinal environment
Scientific Title:Acronym
Study of the effect of ingestion of test food on improving the intestinal environment
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory evaluation of the effect on improving the intestinal environment when the test food is ingested continuously for 8 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of bowel movements / week
Gut microbiota analysis
before, 4 weeks after, and 8 weeks after ingestion.
Key secondary outcomes
Questionnaire on defecation status
Gut microbiota analysis
Stool water content
Stool pH
Fecal putrefactive substances
Short-chain fatty acids in feces
Skin moisture content
Weight, BMI, abdominal circumference
Questionnaire on sleep, stress and fatigue
before, 4 weeks after, and 8 weeks after ingestion.
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest test food A by dissolving it in water or lukewarm water at breakfast every day for 8 weeks.
Interventions/Control_2
Ingest test food B by dissolving it in water or lukewarm water at breakfast every day for 8 weeks.
Interventions/Control_3
Ingest maltodextrin by dissolving it in water or lukewarm water at breakfast every day for 8 weeks.
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Japanese who are 30 years old or more and under 50 years old
3. Those who are aware of constipation tendency (defecate 2 to 5 times / week)
4. Select 60 people with high average similarity regarding the intestinal flora at the time of screening.
Key exclusion criteria
1. Persons who have chronic illness, receiving medication, have a serious disease history
2. Persons who have less than 1 bowel movement / week
3. Persons who are allergic to the test food
4. Persons who usually take a large amount of supplements containing dietary fiber and oligosaccharides
5. Persons who regularly use medicines, foods for specified health use, health foods, etc. that may affect the intestinal environment
6. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
7. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
8. Persons who were judged as inappropriate for study participants by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
masudat@hc-sys.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
masudat@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2021 | Year | 08 | Month | 31 | 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
| 2021 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 15 | 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 | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051762
