UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055811 |
|---|---|
| Receipt number | R000063791 |
| Scientific Title | The effects of test meal intake on the intestinal environment |
| Date of disclosure of the study information | 2024/10/12 |
| Last modified on | 2025/04/11 09:04:01 |
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Basic information
Public title
The effects of test meal intake on the intestinal environment
Acronym
The effects of test meal intake on the intestinal environment
Scientific Title
The effects of test meal intake on the intestinal environment
Scientific Title:Acronym
The effects of test meal intake on the intestinal environment
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the intestinal environment improvement effect on Japanese (20 to 59 years old) by intake of test food for four weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency per week and intestinal microbiota analysis
Key secondary outcomes
Questionnaire (defecation, dietary records, physical condition),
Fecal moisture content, Fecal pH, Fecal putrefactive substances, Fecal short-chain fatty acids,
Urinary indoxyl sulfate levels corrected for creatinine
Body weight, BMI, Waist circumference
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake test meal three times a day before each meal, every day for four weeks
Interventions/Control_2
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.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
2.Persons who are Japanese and 20 years old or more and under 60 years old
3.Persons who tend to be constipated (defecation frequency: 2-5 times per week, with subjective symptoms of constipation)
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who have a history of gastrointestinal surgery (excluding appendectomy or endoscopic polyp removal)
3.Persons who have or have a history of intestinal obstruction, esophageal stenosis, or abnormal intestinal narrowing
4.Persons who are allergic to the test food
5.Persons who are taking supplements containing dietary fiber
6.Persons who regularly take medicine (including laxatives), Chinese medicine, foods with health claims (foods for specified health uses, foods with functional claims, and foods with nutritional claims) that may affect the intestinal environment
7.Persons whose daily water intake is extremely low
8.Persons who have a habit of skipping meals
9.Persons who cannot prepare and consume the test food three times a day before each meal as instructed
10.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
11.Persons who were judged as inappropriate for study participants by the principal investigator
12.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuma |
| Middle name | |
| Last name | Toda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
toda.kazuma@hc-sys.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Toda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
1050004
Address
Park Place 5F, 5-27-1 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
Homepage URL
toda.kazuma@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOODS HOLDINGS 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
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, 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
| 2024 | Year | 10 | 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
30
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
| 2024 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063791
