UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054807 |
|---|---|
| Receipt number | R000062350 |
| Scientific Title | Safety Confirmation and Exploratory Index Research on Excessive Intake of Research Food Placebo-controlled, randomized, double-blind, parallel-group comparative method |
| Date of disclosure of the study information | 2024/07/19 |
| Last modified on | 2024/06/28 13:11:31 |
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Basic information
Public title
Safety Confirmation and Exploratory Index Research on Excessive Intake of Research Food
Placebo-controlled, randomized, double-blind, parallel-group comparative method
Acronym
Safety Confirmation and Exploratory Index Research on Excessive Intake of Research Food
Scientific Title
Safety Confirmation and Exploratory Index Research on Excessive Intake of Research Food
Placebo-controlled, randomized, double-blind, parallel-group comparative method
Scientific Title:Acronym
Safety Confirmation and Exploratory Index Research on Excessive Intake of Research Food
Region
| Japan |
Condition
Condition
Healthy male/female volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of the excess volume of the test food for four consecutive weeks. In addition, an exploratory index investigation will be conducted by ingestion of the test food.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Questionnaire and subjective and objective symptoms (including adverse events and subjective symptoms recorded in the diary)
2. body weight (BMI)
3. Blood pressure and pulse rate
4. Clinical examination
Hematology, biochemistry, urinalysis
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
High daily intake of test food, continuous for 4 weeks
Interventions/Control_2
Low daily intake of test food, continuous for 4 weeks
Interventions/Control_3
Control food consumed continuously 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese men and women who are at least 20 years old and less than 65 years old at the time consent is obtained.
(2) Those who have been fully informed of the purpose and content of the research, have the capacity to consent, and have voluntarily volunteered to participate in the research based on sufficient understanding of the purpose and content of the research, and have agreed to participate in the research in writing.
Key exclusion criteria
(1) Those who have serious renal or hepatic disease, cardiac, respiratory, endocrine, or other metabolic diseases, or are under treatment for such diseases.
(2) Those who have chronic diseases and use medicines regularly.
(3) Those who have gastrointestinal diseases affecting digestion and absorption and those who have a history of gastrointestinal surgery (except appendicitis).
(4) Those who cannot stop taking supplements or health foods (including food for specified health uses and functional foods) during the research period.
(5) Those who have a history or current medical history of drug dependence or alcohol dependence.
(6) Those who are unable to stop drinking alcohol for 2 days prior to all tests.
(7) Those who are judged by the principal investigator to be unsuitable as research subjects based on blood tests performed during the screening tests.
(8) Those who have reported that they are allergic to any of the ingredients of the study foods.
(9) Those who are currently participating in, or intend to participate in, research (studies) involving the ingestion of other foods or the use of drugs, or the application of cosmetics and medicines, or those who have participated in other clinical research within one month of obtaining consent.
(10) Those who have donated blood or component blood more than 200 mL within 1 month or 400 mL within 3 months prior to the date of obtaining consent.
(11) Those who are pregnant, intend to become pregnant during the study period, may become pregnant, or are breastfeeding.
(12) Any other persons judged by the Principal Investigator to be inappropriate as research subjects.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Tokushima |
Organization
Maebashi North Hospital
Division name
Director
Zip code
371-0054
Address
692 Shimohosoi-machi, Maebashi, Gunma
TEL
027-235-3333
sagawa@mc-connect.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numazu |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
7F Shibaura-Omodaka Building,1-9-7 Shibaura,Minato-ku,Tokyo,Japan
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TEIJIN LIMITED
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 Kobuna Orthopedics Clinic
Address
5-656-17Joutou-machi,Maebashi-shi,Gunma
Tel
027-212-5608
sagawa@mc-connect.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
| 2024 | Year | 07 | Month | 19 | 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
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 28 | 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 | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062350
| 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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| Registered date | File name |
