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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028519
Receipt No. 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

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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
Email 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
Email yoshi@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032635

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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