UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028519 |
|---|---|
| Receipt number | R000032635 |
| Scientific Title | A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects. A Randomized, Double-blind, Placebo controlled Study. |
| Date of disclosure of the study information | 2017/08/04 |
| Last modified on | 2019/02/13 13:17:41 |
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Basic information
Public title
A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects.
A Randomized, Double-blind, Placebo controlled Study.
Acronym
A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects.
Scientific Title
A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects.
A Randomized, Double-blind, Placebo controlled Study.
Scientific Title:Acronym
A Study of the Effect of Test Supplement on Oxidative Stress in healthy subjects.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of test supplement on oxidative stress in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the effects on Measurement items related to oxidative stress
Key secondary outcomes
Evaluate the effects on mental and physical conditions by questionnaires and related-measurement items
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
Ingestion of test food for 12 weeks
Interventions/Control_2
Ingestion of placebo food for 12 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Subjects with rather high level of HbA1c.
(2) Subjects who were judged to have a high level of oxidative stress from the results of screening tests.
(3) Subjects who understand objectives and protocol of this study with written consent.
Key exclusion criteria
(1) Subjects who have serious diseases requiring an urgent treatment, or who have chronic illness and use medicines constantly.
(2) Subjects who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement (except for appendectomy.)
(3) Subjects who use supplements and health foods (including food for specified health use and food with nutrient function claims) constantly that could affect antioxidant status
(4) Subjects who ingest many polyphenol-containing beverages such as green tea and coffee (more than 3 cups per day).
(5) Subjects who declared that they have allergies to the ingredients of the test supplement.
(6) Subjects who have a history of developing seasonal allergy during this study period (July - December).
(7) Subjects who are pregnant or willing to be pregnant or breast-feeding during this study.
(8) Subjects who have a current or history of drug dependence and/or alcoholism.
(9) Subjects who were judged as unsuitable for this study by the principal investigator from the clinical examination performed in the screening test.
(10) Subjects who are participating in other clinical trial that intake/apply any of food, drug, and cosmetics, or willing to participate.
(11) Subjects who are judged unsuitable for this study by the principal investigator.
Target sample size
112
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshika Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Holdings, 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
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
| 2017 | Year | 08 | Month | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 04 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 03 | Day |
Last modified on
| 2019 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032635
