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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031653
Receipt No. 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

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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
Email 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
Email e-yagi@immudyne.co.jp

Sponsor
Institute IMMUDYNE INC.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036149

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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