UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety evaluation of an excessive consumption of Bilberry extract and Lutein
Title of the study (Brief title)	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	Marie Kosehira
Organization	Omnica Co.,Ltd
Division name	Research and development Dept.
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	Marie Kosehira
Organization	Omnica Co.,Ltd
Division name	Research and development Dept.
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 22 Day
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

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Publication of results	Unpublished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