UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of supplement containing pycnogenol on oxidative-stress marker
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hajime Orimo
Organization	Kenkoin Clinic
Division name	Director
Address	6-7-4Ginza, Chuo-ku, Tokyo,104-0061
TEL	03-3573-1153
Email	hajime-orimo@kenkoin.jp

Public contact
Name of contact person	Chie Tarumizu
Organization	FANCL Corporation
Division name	Research Institute
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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