UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058330 |
|---|---|
| Receipt number | R000066676 |
| Scientific Title | Safety evaluation of long term (12 weeks) intake of test food |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/30 19:10:37 |
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Basic information
Public title
Safety evaluation of long term (12 weeks) intake of test food
Acronym
Safety evaluation of long term (12 weeks) intake of test food
Scientific Title
Safety evaluation of long term (12 weeks) intake of test food
Scientific Title:Acronym
Safety evaluation of long term (12 weeks) intake of test food
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to confirm the safety of long-term (12-week) continuous intake of the test food
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(Safety evaluation)
Vital signs, physical measurements (weight, BMI), blood biochemistry, hematology, urinalysis, adverse events, The Japanese version of the Pittsburgh Sleep Quality Index
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
Continuous intake of test foods for 12 weeks
Interventions/Control_2
Continuous intake of control foods 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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women aged between 50 and 75 years old at the time of obtaining written consent.
2.Subjects who have received sufficient explanation of the purpose and content of the research, and have the ability to consent.
Key exclusion criteria
1.Subjects who have been diagnosed with dementia by a doctor.
2.Subjects who have a history of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption. (excluding appendicitis)
3.Subjects who have food allergy.
4.Subjects who have a history of drug dependence or alcohol dependence or have a current medical history.
5.Subjects who have irregular lifestyles due to night shifts or shift work.
6.Subjects with extremely irregular lifestyle habits in terms of eating and sleeping.
7.Subjects who consistently drink more than the recommended amount of alcohol (average net alcohol intake of over 40 g/day).
8.Subjects who have a history or current illness of serious diseases such as brain disease, malignant tumor, immune disease, kidney disease, liver disorder, cardiovascular disorder, endocrine disorder, or other metabolic disorders.
9.Subjects who have a habit of consuming Camembert cheese (2 pieces a day, 5 days a week or more).
10.Subjects who are participating in other clinical studies now, or are willing to participate within 3 months prior to the date of obtaining consent.
11.Subjects who has participated in blood collection or donation of more than 200 mL within 1 month or more than 400 mL within 3 months prior to the date of obtaining consent.
12.Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
13.Subjects who are judged to be inappropriate as research subjects according to data in screening tests.
14.Subjects who are judged unsuitable for the study by the investigator for other reasons.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan
TEL
03-3431-1260
rd@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan
TEL
03-3431-1260
Homepage URL
rd@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
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
Tokyo Shinjuku Clinic Ethical Review Board
Address
5F,SIL Shinjuku-building,2-46-3,Kabukicho,Shinjuku-ku,Tokyo,160-0021,Japan
Tel
03-6709-6071
tokyoshinjuku@taifukukai.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 | 07 | Month | 01 | 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 | 06 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066676
