UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053003 |
|---|---|
| Receipt number | R000060202 |
| Scientific Title | Long-Term Safety Confirmation Trial of a Test Food Product A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2024/08/07 20:13:24 |
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Basic information
Public title
Long-Term Safety Confirmation Trial of a Test Food Product
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study
Acronym
Long-Term Safety Confirmation Trial of a Test Food Product
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study
Scientific Title
Long-Term Safety Confirmation Trial of a Test Food Product
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study
Scientific Title:Acronym
Long-Term Safety Confirmation Trial of a Test Food Product
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Study
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety of long-term consumption (12 weeks) of a test food in daily life by comparing it with a control food.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events and side effects.
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
Consumption of the test food (1 bottle a day) for 12 weeks
Interventions/Control_2
Consumption of the placebo food (1 bottle a day) 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Males and females aged 20 to 59 years old.
2. Subjects whose body mass index (BMI) is included between 18.5 kg/m2 to less than 30.0 kg/m2
3. Subjects who take regular meals three times a day.
4. Subjects who can abstain from alcohol 2 days before each test.
5. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who regularly consume food products containing lactobacilli or bifidobacteria, foods fortified with oligosaccharides or dietary fiber, and health food products claimed to improve bowel movements or intestinal environment (including Food for Specified Health Uses (FOSHU) and Foods with Function Claims), and/or who cannot refrain from consuming these during the trial period.
2. Subjects who are unable to refrain from consuming large amounts of fermented foods such as natto or kimchi, other health foods, or sugar alcohol-containing foods like xylitol or erythritol.
3. Subjects who regularly use supplements or health foods (including Foods with Function Claims) that may affect immune function and cannot refrain from consuming these during the trial period.
4. Subjects with a past or present history of serious diseases including cardiac, hepatic, renal, gastrointestinal (including those with surgery affecting digestion and absorption), drug dependence, or alcohol dependence.
5. Subjects who regularly experience constipation and diarrhea alternately in their daily life.
6. Subjects with chronic diseases.
7. Subjects who are on regular medication.
8. Subjects who have taken antibiotics or other medications that could affect the intestinal environment or digestion and absorption on the day of the preliminary examination.
9. Subjects who consistently consume alcohol in amounts exceeding moderate drinking (approximately 20 g of pure alcohol per day).
10. Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
11. Subjects who have smoking habit.
12. Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
13. Subjects deemed unsuitable as study subjects based on blood tests conducted during the preliminary examination.
14. Subjects who are intolerant to lactose.
Target sample size
30
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, Japan
TEL
0362259001
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
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
0362259001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
0362259005
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
| 2025 | Year | 06 | Month | 30 | 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
The long-term consumption (12 weeks) of food containing approximately 1x10^10 CFU/day (average 1.09x10^10 CFU/day, 2.45x10^10 cells/day) of lactic acid bacteria in daily life was considered to be safe.
Results date posted
| 2024 | Year | 08 | Month | 07 | Day |
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
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 22 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 04 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 11 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 25 | Day |
Other
Other related information
(Exclusion criteria continued)
15. Females who are pregnant or lactating, and females who could become pregnant or lactating during study period.
16. Subjects who have previous medical history of drug and/or food allergy.
17. Subjects who donated blood or component (200 mL) within the last 1 months.
18. Subjects who donated his blood (400 mL) within the last 3 months.
19. Subjects who donated her blood (400 mL) within the last 4 months.
20. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this research.
21. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this research.
22. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Management information
Registered date
| 2023 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060202
