UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056276 |
|---|---|
| Receipt number | R000064255 |
| Scientific Title | Safety evaluation of an excessive consumption of test food |
| Date of disclosure of the study information | 2024/11/27 |
| Last modified on | 2025/10/31 15:41:08 |
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Basic information
Public title
Safety evaluation of an excessive consumption of test food
Acronym
Safety evaluation of an excessive consumption of test food
Scientific Title
Safety evaluation of an excessive consumption of test food
Scientific Title:Acronym
Safety evaluation of an excessive consumption of test food
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive consumption of test food.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of adverse events, number of cases, and frequency of adverse events related to the intake of the study foods, medical interview, weight/body mass index, blood pressure/pulsation, hematologic test, blood biochemistry test, urine analysis and 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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of Test food A containing 5 folds dose of recommended daily intake of the functional substance, for 4 weeks.
Interventions/Control_2
Ingestion of Test food B containing 5 folds dose of recommended daily intake of the functional substance, for 4 weeks.
Interventions/Control_3
Ingestion of control food for 4 weeks.
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. Males and females from 50 to under 75 years of age.
2. Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1. 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, respiratory disorder, endocrine disorder, or other metabolic disorders.
2. Subjects who have a history of drug dependence or alcohol dependence or have a current medical history.
3. Subjects who have a history of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption. (excluding appendicitis)
4. Subjects who have been diagnosed with dementia by a doctor.
5. Subjects who are judged to be inappropriate as research subjects according to blood tests in screening tests.
6. Subjects who has food allergy.
7. Subjects who cannot consume cheese every day.
8. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
9. 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.
10. Subjects who have a habit of consuming Camembert cheese (2 pieces a day, 5 days a week or more).
11. Subjects who consistently drink more than the recommended amount of alcohol (average net alcohol intake of over 40 g/day, 4 days a week or more).
12. Subjects who have irregular lifestyles due to night shifts or shift work.
13. Subjects with extremely irregular lifestyle habits in terms of eating and sleeping.
14. Subjects who cannot receive refrigerated deliveries.
15. Subjects who are participating in other clinical studies that require taking foods, pharmaceuticals, or using cosmetics now, or are willing to participate within 3 months prior to the date of obtaining consent.
16. Subjects who are judged unsuitable for the study by the investigator for other reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
Meiji Co., Ltd.
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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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
日本橋循環器科クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 27 | 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
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 16 | 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 | 11 | Month | 26 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064255
