UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049913 |
|---|---|
| Receipt number | R000056818 |
| Scientific Title | A study to confirm the safety of overdose of test food: a randomized, double-blind, placebo-controlled trial. |
| Date of disclosure of the study information | 2022/12/27 |
| Last modified on | 2022/12/27 09:48:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to confirm the safety of overdose of test food: a randomized, double-blind, placebo-controlled trial.
Acronym
A study to confirm the safety of overdose of test food.
Scientific Title
A study to confirm the safety of overdose of test food: a randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym
A study to confirm the safety of overdose of test food.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of overdose of test food.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Medical interview
2. Height / weight (BMI)
3. Blood pressure / Pulse rate
4. Hematology test
5. biochemical test
6. Urinalysis
7. Subjective and Objective symptom
8. Adverse event
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
Take 10 capsules of the test food once a day around 10:00 am for 4 weeks.
Interventions/Control_2
Take 5 capsules of the test food and 5 capsules of the control food once a day around 10:00 am for 4 weeks.
Interventions/Control_3
Take 10 capsules of the control food once a day around 10:00 am 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. Males and females from 20 to 64 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 of Serious diseases such as diabetes, kidney/liver disease or heart disease, and/or thyroid diseases, adrenal diseases, and other metabolic diseases or who is under medical treatment.
2. Subjects who have chronic disease and is under medication.
3. Subjects who have a history of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption.
4. Subjects who have a history of drug dependence or alcohol dependence or have a current medical history.
5. Those who consistently drink more than the recommended amount of alcohol.
6. Subjects who cannot abstain from drinking 2 days before each test.
7. Subjects who has food allergy.
8. Subjects who are judged to be inappropriate as research subjects by blood tests in screening tests.
9. Subjects who has collected or donated more than 200 mL of blood or blood components within 1 month or more than 400 mL of blood or blood within 3 months prior to the date of obtaining consent.
10. Subjects who are participating in other studies that using foods, pharmaceuticals, and cosmetics now, or are willing to participate.
11. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
12. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
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-shi,Gumma
TEL
027-235-3333
sagawa@mc-connect.co.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
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
5-656-17 Joto-machi, Maebashi-shi, Gumma
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
| 2022 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
Protocol is unpublished, due to including confidential information.
Publication of results
Unpublished
Result
URL related to results and publications
Results is published in only UMIN
Number of participants that the trial has enrolled
30
Results
Safety was confirmed.
Results date posted
| 2022 | Year | 12 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy subjects
Participant flow
30 participants completed and 30 subjects were incorporated into the analyses.
Adverse events
No adverse effect related to the test foods reported.
Outcome measures
Safety
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 27 | 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 | 12 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056818
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
