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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025414
Receipt No. R000029256
Scientific Title Safety evaluation of an excessive consumption of Bilberry extract and Lutein
Date of disclosure of the study information 2016/12/26
Last modified on 2017/12/28

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Basic information
Public title Safety evaluation of an excessive consumption of Bilberry extract and Lutein
Acronym Safety evaluation of an excessive consumption of Bilberry extract and Lutein
Scientific Title Safety evaluation of an excessive consumption of Bilberry extract and Lutein
Scientific Title:Acronym Safety evaluation of an excessive consumption of Bilberry extract and Lutein
Region
Japan

Condition
Condition Nothing (healthy subject)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of excessive consumption of Bilberry extract and Lutein
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hematologic test (0w,2w,4w,6w)
Key secondary outcomes Body measurement(0w,6w)
Blood biochemical test (0w,2w,4w,6w)
Urine analysis (0w,2w,4w,6w)
Doctor's questions (0w,6w)
Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Bilberry extract 240mg and Lutein 120mg,4weeks
Interventions/Control_2
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
60 years-old >
Gender Male and Female
Key inclusion criteria 1. Healthy Japanese males and females
2. BMI>=18.5 and <25 kg/m2
Key exclusion criteria 1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who are patient or have history of cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
3. Subjects who have undergone gastrointestinal tract surgery; except appendectomy
4. Subjects who are currently taking medicines (include herbal medicines) and/or supplements
5. Subjects who are allergic to medicines or the test material of this trial
6. Subjects who are or are possibly pregnant, or are lactating
7. Subjects who participate in other clinical trials in the past 3 months
8. Subjects who work time is irregular
9. Subjects who have been determined ineligible by principal investigator for other reasons
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Marie Kosehira
Organization Omnica Co.,Ltd
Division name Research and development Dept.
Zip code
Address TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5840-9811
Email kosehira@omnica.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Marie Kosehira
Organization Omnica Co.,Ltd
Division name Research and development Dept.
Zip code
Address TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL 03-5840-9811
Homepage URL
Email kosehira@omnica.co.jp

Sponsor
Institute Omnica Co.,Ltd
Institute
Department

Funding Source
Organization Omnica Co.,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 医療法人財団 百葉の会 銀座医院(東京)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 26 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
2016 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 26 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
2016 Year 12 Month 26 Day
Last modified on
2017 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029256

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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