UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019211 |
|---|---|
| Receipt number | 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 15:50:56 |
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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
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
Chie_0904@fancl.co.jp
Sponsor or person
Institute
Kenkoin Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022207
