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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019211
Receipt No. R000022207
Scientific Title Effect of supplement containing pycnogenol on oxidative-stress marker
Date of disclosure of the study information 2015/10/02
Last modified on 2016/05/24

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Basic information
Public title Effect of supplement containing pycnogenol on oxidative-stress marker
Acronym Effect of supplement containing pycnogenol on oxidative-stress marker
Scientific Title Effect of supplement containing pycnogenol on oxidative-stress marker
Scientific Title:Acronym Effect of supplement containing pycnogenol on oxidative-stress marker
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate the effect of supplement containing pycnogenol on oxidative-stress marker in healthy volunteer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oxidant stress marker after four weeks of intervention
Antioxidant marker after four weeks of intervention
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 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingestion of supplement containing Pycnogenol for 4 weeks
Interventions/Control_2 Ingestion of placebo without Pycnogenol for 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
50 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria Males and females aged 50 to 69 years with high oxidative stress level.
(d-ROMs : More than 321.CARR)
Key exclusion criteria 1)Subjects who use supplements or functional foods affecting Antioxidant marker
2)Subjects who receive treatment of medication or outpatient or therapy
3)Subjects who have smoked within the last six month prior to the current study
4)Subjects who have allergy to gelatin
5)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Orimo
Organization Kenkoin Clinic
Division name Director
Zip code
Address 6-7-4Ginza, Chuo-ku, Tokyo,104-0061
TEL 03-3573-1153
Email hajime-orimo@kenkoin.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chie Tarumizu
Organization FANCL Corporation
Division name Research Institute
Zip code
Address Kamishinano 12-13, Totsuka-ku, Yokohama, Kanagawa, 244-0806
TEL 045-820-3443
Homepage URL
Email Chie_0904@fancl.co.jp

Sponsor
Institute Kenkoin Clinic
Institute
Department

Funding Source
Organization FANCL Corporation
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
2015 Year 10 Month 02 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
2015 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 03 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
2015 Year 10 Month 02 Day
Last modified on
2016 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022207

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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