UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060427 |
|---|---|
| Receipt number | R000069024 |
| Scientific Title | A safety study on long-term consumption of a yogurt drink. |
| Date of disclosure of the study information | 2026/01/22 |
| Last modified on | 2026/01/21 17:49:25 |
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Basic information
Public title
A safety study on long-term consumption of a yogurt drink.
Acronym
A safety study on long-term consumption of a yogurt drink.
Scientific Title
A safety study on long-term consumption of a yogurt drink.
Scientific Title:Acronym
A safety study on long-term consumption of a yogurt drink.
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of 12 weeks consumption of a yogurt drink in a randomized, double-blind, placebo-controlled, parallel-group trial.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of subjects and events for adverse events (AEs) and for AEs related to the study products.
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
Oral intake of the test food (yogurt drink, 112 g) once daily for 12 weeks.
Interventions/Control_2
Oral intake of placebo food (acidified milk, 112 g) daily for 12 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese male and female aged 20 to 64 years at the time of consent.
(2) Subjects with a BMI >= 18.5 and < 30.0.
(3) Subjects who provide written informed consent.
Key exclusion criteria
(1) Subjects who have serious disease.
(2) Subjects who have taken any medication within 3 days prior to the screening test.
(3) Subjects with an average daily alcohol intake exceeding 40 g.
(4) Subjects unable to abstain from alcohol for 1 day prior to the examination.
(5) Subjects whose daily routines are irregular due to night work or shift work.
(6) Subjects who are expected to be unable to consume the study food for 6 or more days due to extended travel or similar circumstances.
(7) Subjects have participated in other research within 4 weeks prior to consent or plan to participate in other research after consent.
(8) Subjects who are pregnant, breastfeeding or intend to become pregnant during this study.
(9) Subjects who tend to develop diarrhea after consuming dairy products.
(10) Subject with food allergies.
(11) Subjects who donated blood component or 200 mL of whole blood within 1 month before this study.
(12) Males who donated 400 mL of whole blood within 3 months before this study.
(13) Females who donated 400 mL of whole blood within 4 months before this study.
(14) Males whose total blood draw volume, including the planned volume for this study, exceeds 1,200 mL within 12 months before this study.
(15) Females whose total blood draw volume, including the planned volume for this study, exceeds 800 mL within 12 months before this study.
(16) Subjects deemed unsuitable by the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda Paramedical Care Clinic
Division name
Director
Zip code
103-0021
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo
TEL
03-6225-9505
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Director
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo
TEL
03-6625-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
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
| 2026 | Year | 01 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069024
