UMIN-CTR Clinical Trial

Basic information
Public title	A study evaluating the efficacy of botanical ingredient-containing food on eye strain.
Acronym	A study evaluating the efficacy of botanical ingredient-containing food on eye strain.
Scientific Title	A study evaluating the efficacy of botanical ingredient-containing food on eye strain.
Scientific Title:Acronym	A study evaluating the efficacy of botanical ingredient-containing food on eye strain.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy of the botanical ingredient-containing food on eye strain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	High Frequency Component 1
Key secondary outcomes	Visual Analogue Scale questionnaire

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Prevention
Type of intervention	Food
Interventions/Control_1	Botanical ingredient-containing food
Interventions/Control_2	Botanical ingredient-not containing food
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Individuals aged from 20 to 65 years, when giving the informed consent. (2)Individuals who are aware of eye strain. (3)Individuals giving the written informed consent.
Key exclusion criteria	(1)Individuals who use medication or supplements or functional foods affecting eye strain. (2)Individuals who is not suitable for subjects by pre-test questionnaire. (3)Individuals who declare the allergy symptoms against test diets. (4)Individuals who have a chronic disease and use medicines continuously, or have a history of chronic disease. (5)Individuals who have a history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder, or have a history of these disease. (6)Individuals who have a history of digestive disease affecting digestion and absorption. (7)Individuals who have ophthalmologic disease, or have a history of ophthalmologic disease. (8)Individuals who is not suitable for subjects by pre-test. (9)Individuals who are planned to participate in other clinical study. (10)Individuals who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study or over 400 mL of blood and/or blood component within the last three months prior to the current study. (11)Individuals with excessive alcohol-drinking behaviors. (12)Individuals who can't stop drinking for the days before the pre-check day and check days. (13)Individuals who have under treatment or a history of drug addiction and/or alcoholism. (14)Individuals who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. (15)Individuals who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuji Kawachi
Organization	Kirin Company
Division name	Research & Development Division, Resarch Laboratories for Health Science & Food Technologies
Zip code
Address	1-17-1, Namamugi, Tsurumi-ku, Yokohama, Kanagawa
TEL	045-500-6970
Email	Yasuji_Kawachi@kirin.co.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuji Kawachi
Organization	Kirin Company
Division name	Research & Development Division, Resarch Laboratories for Health Science & Food Technologies
Zip code
Address	1-17-1, Namamugi, Tsurumi-ku, Yokohama, Kanagawa
TEL	045-500-6970
Homepage URL
Email	Yasuji_Kawachi@kirin.co.jp

Sponsor
Institute	Kirin Company
Institute
Department

Funding Source
Organization	Kirin Company
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	キリン株式会社

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 14 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	2017 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date	2017 Year 03 Month 16 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	2017 Year 03 Month 15 Day
Last modified on	2017 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030502

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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