UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050001 |
|---|---|
| Receipt number | R000056731 |
| Scientific Title | Validation study of the effects on gut microenvironment by test-beverage intakes |
| Date of disclosure of the study information | 2024/01/14 |
| Last modified on | 2024/10/08 11:40:17 |
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Basic information
Public title
Validation study of the effects on gut microenvironment by test-beverage intakes
Acronym
Validation study of the effects on gut microenvironment by test-beverage intakes
Scientific Title
Validation study of the effects on gut microenvironment by test-beverage intakes
Scientific Title:Acronym
Validation study of the effects on gut microenvironment by test-beverage intakes
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate some kind of effect by ingesting the test beverage for four weeks on gut microenvironment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal flora
Key secondary outcomes
1. Physical and chemical analysis of stool and urine samples
2. Questionnaire about defecation status and health-related Quality of Life
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
Ingestion of the test beverage (1 bottle a day) to the subjects, principally at breakfast for 4 weeks.
Interventions/Control_2
Ingestion of the placebo beverage (1 bottle a day) to the subjects, principally at breakfast 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) Japanese healthy male/female subjects ranging in age from 20 to 59, at informed consent.
(2) Subjects ranging in defection frequency from not less than three times to less than six times a week.
(3) Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
Subjects - -
(1) who take in affecting health-specific/functional/supplementary/health foods, lactic acid drinks (including yogurt drinks), or bifidobacterial beverages, over twice a week,
(2) who take in yogurt, over 3 times a week,
(3) who take in oligosaccharide and dietary fiber, over twice a week,
(4) not having a habit of drinking milk, over once a week,
(5) who have taken affecting medicines (gut/digestive/constipation/laxative regulation), over once a week,
(6) having loose stools, owing to milk or cold beverage ingestion,
(7) having a tendency to repeat constipation and diarrhea,
(8) having a tendency to increase a defecation frequency by continuous intakes of water (0.1 L),
(9) having constipation and diarrhea, owing to a menstruation,
(10) with over 30.0 kg/m2 of BMI,
(11) with frequency in going out, below twice a week,
(12) with heavy smoking and excessive alcohol,
(13) who have been on antibiotics after the pre-test to the hospital visiting (0 W),
(14) planning to go on a long or trip abroad after the pre-test and during this study,
(15) with extremely irregular eating habits / life rhythm,
(16) having medical history of severe cardiac, hepatic, renal or digestive diseases,
(17) with pregnancy, possibly one, or lactating,
(18) having drug and food allergy (especially to milk and soybean),
(19) being under another clinical test with medicine or health food, or partook in that within the past 4 weeks, or will partake in that after the consent,
(20) who donated their blood components or blood (0.2 L) within the last month,
(21) who donated his blood (0.4 L) within the past 3 months,
(22) who donated her blood (0.4 L) within the past 4 months,
(23) being collected in total of his blood (1.2 L) within the past 12 months and in this study,
(24) being collected in total of her blood (0.8 L) within the past 12 months and in this study,
(25) determined as ineligible for participation, judging from the principal/sub investigator - - .
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
| 2024 | Year | 01 | Month | 14 | 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 | 12 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 25 | 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 | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056731
