UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049370 |
|---|---|
| Receipt number | R000056208 |
| Scientific Title | Safety Confirmation Test by Long-term Consumption of Test Food |
| Date of disclosure of the study information | 2022/12/16 |
| Last modified on | 2023/10/24 15:00:30 |
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Basic information
Public title
Safety Confirmation Test by Long-term Consumption of Test Food
Acronym
Safety Confirmation Test by Long-term Consumption of Test Food
Scientific Title
Safety Confirmation Test by Long-term Consumption of Test Food
Scientific Title:Acronym
Safety Confirmation Test by Long-term Consumption of Test Food
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety Confirmation by Long-term Consumption of Test Food
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematological tests
Blood Biochemistry
Urinalysis
Height, weight, BMI
Measurement of systolic and diastolic blood pressure and pulse rate
Interview by physician
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Tablets containing 600 mg of hydrous ethanol extract of plant seeds
Interventions/Control_2
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy and free from chronic physical disease.
The applicant must be able to give consent to participate in the study in writing after having been fully informed of the purpose and content of the study and having the ability and understanding of the study.
The applicant must be able to come to the hospital on the designated date and undergo the examination.
Those who are deemed suitable by the investigator to participate in the study.
Key exclusion criteria
Those who are currently undergoing drug treatment for some disease.
Patients with a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
Patients with a history of co-morbidities or a history of gastrointestinal disorders.
Patients with alcohol dependence or other psychiatric disorders
Patients who have taken any medication for the purpose of treatment of disease in the past 1 month (except for abrupt administration of medication for headache, menstrual cramps, common cold, etc.).
The specific hay fever symptoms include: Birch: alder, birch, cedar, Japanese cypress; Asteraceae: ragweed, mugwort; Poaceae: ragweed, mugwort; Poaceae: chamogaya, Japanese mugwort; and Poaceae: Japanese knotweed, Japanese millet.
Persons who may develop allergic symptoms to any of the ingredients in the tested foods, or who may develop serious allergic symptoms to other foods or medicines.
Persons with severe anemia
Persons who have a smoking habit.
Women: Pregnant, lactating, or planning to become pregnant during the study period.
Those who may change their lifestyle during the study period (e.g., work at night, travel for long periods, etc.).
Those who are currently, or within the past 3 months have been, or will be taking functional foods, health foods, or supplements containing the ingredients of the food under study.
Those who have undergone medical treatment involving hospitalization within the past 6 months.
Those who have participated in other clinical studies within one month of obtaining consent to participate in this study, or those who plan to participate in other clinical studies after obtaining consent to participate in this study.
Other subjects who are judged by the investigator to be inappropriate for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kawama |
Organization
MORINAGA & CO., LTD.
Division name
R & D Center
Zip code
230-8509
Address
2-1-1 Shimosueyoshi Tsurumi-ku Yokohama-si Kanagawa-ken
TEL
045-571-6140
t-kawama-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Sadao |
| Middle name | |
| Last name | Mori |
Organization
MORINAGA & CO., LTD.
Division name
R & D Center
Zip code
230-8509
Address
2-1-1 Shimosueyoshi Tsurumi-ku Yokohama-si Kanagawa-ken
TEL
045-571-6140
Homepage URL
s-mori-ab@morinaga.co.jp
Sponsor or person
Institute
Akasaka Family Clinic
Institute
Department
Personal name
Funding Source
Organization
MORINAGA & 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
NPO-MINS Clinical Trial Review Committee
Address
2F, 1-15-14 Dogenzaka, Shibuya-ku, Tokyo 150-0043, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2022 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
19
Results
Published at Jpn. Pharmacol. Ther. vol.51, no.6, pp.877-892 (2023)
Results date posted
| 2023 | Year | 10 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 06 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 31 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056208
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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