UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031653 |
|---|---|
| Receipt number | R000036149 |
| Scientific Title | Examination of safety of supplement and usefulness for antioxidant preliminary examination test |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2018/03/09 15:35:18 |
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Basic information
Public title
Examination of safety of supplement and usefulness for antioxidant preliminary examination test
Acronym
Examination of safety of supplements and usefulness of preliminary study
Scientific Title
Examination of safety of supplement and usefulness for antioxidant preliminary examination test
Scientific Title:Acronym
Examination of safety of supplements and usefulness of preliminary study
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preliminary study to confirm safety by ingesting antioxidant supplements and whether oxidative marker is decreased and improvement of stress and fatigue is observed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Blood test and urinalysis
d-ROM, BAP, 8-OHdG, high-sensitivity CRP
*Test point: 0 week, 2 weeks, 4 weeks,
Key secondary outcomes
*Profile of Mood States 2nd Edition (Japanese version) results
*PSQI questionnaire
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
test food: 4 weeks
Interventions/Control_2
Base food: 4 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
*20 to 80 years old at the time of consent acquisition
*Female
*Japanese adult women who are not treating diseases that recognize fatigue everyday
*Who agreed to participate in the study.
Key exclusion criteria
*Those who regularly use health supplements containing antioxidant ingredients such as vitamin C
*Persons with a history of treatment of malignant tumor, heart failure, myocardial infarction
*Those who are being treated with the following chronic diseases (arrhythmia, liver disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, and neuropsychiatric disorders)
*Those who regularly use medicines(including herbal medicine), supplements
*Those who regularly use foods for specified health use and functional display foods
*One who has allergy to ingredients contained in the test food
*Anyone who is willing to pregnant, lactating or intending to become pregnant during the study
*Persons who have participated in other clinical trials during the three months prior to the acquisition date of consent
*Others who judged that the examination responsible doctor is inappropriate as the subject of this exam
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Sakata |
Organization
IMMUDYNE INC.
Division name
IMMUDYNE INC. Development Dept.
Zip code
Address
Ohara Bldg. 6F, 5-7-17, Minami Aoyama, Minato-ku, Tokyo 107-0062, Japan
TEL
03-5467-6284
e-yagi@immudyne.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiichiro Yagi |
Organization
IMMUDYNE INC.
Division name
IMMUDYNE INC. Development Dept.
Zip code
Address
Ohara Bldg. 6F, 5-7-17, Minami Aoyama, Minato-ku, Tokyo 107-0062, Japan
TEL
03-5467-6284
Homepage URL
e-yagi@immudyne.co.jp
Sponsor or person
Institute
IMMUDYNE INC.
Institute
Department
Personal name
Funding Source
Organization
IMMUDYNE INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 09 | Day |
Last modified on
| 2018 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036149
