UMIN-CTR Clinical Trial

Basic information
Public title	Effect of supplement on contrast sensitivity : a pilot study
Acronym	Effect of test supplement on contrast sensitivity
Scientific Title	Effect of supplement on contrast sensitivity : a pilot study
Scientific Title:Acronym	Effect of test supplement on contrast sensitivity
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to verify the effect of test supplement on contrast sensitivity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Contrast sensitivity
Key secondary outcomes	Macular pigment optical density, Subjective symptom questionnaire, Visual acuity, Best corrected visual acuity, Serum lutein and zeaxanthin concentration

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test supplement for 24 consecutive weeks
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	45 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Subjects aged from 45 to 65 years old (2) Subjects with low contrast sensitivity
Key exclusion criteria	(1) Subjects who have eye disease except refractive errors (e.g., Macular disease, optic media with advanced abnormalities) (2) Subject who are myopia over -6D (3) Subject who are daily corrected visual acuity less than 0.7 in both eyes (4) Subjects who are best corrected visual acuity of less than 1.0 (5)Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) (6)Subjects who have history of surgical resection of the gastrointestinal tract (except for appendectomy) (7) Subjects who routinely take lutein or zeaxanthin containing supplement within the past year (8) Subjects who have history of smoking within the past year (9) Subjects who routinely take medicine (including eye drops) or health foods that may affect the results of this study (10) Subjects who may have symptoms of hay fever during study period (11) Subjects having possibilities for emerging allergy related to the study (12) Subjects who are in long-term treatment (including medication, hospitalization, diet and exercise therapy )or are planning to take treatment during study period (13) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (14) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on baseline examination (15) Subjects who intend to become pregnant or lactating (16) Subjects who have participated in other clinical study (17) Subjects who are judged as unsuitable by doctor for other reasons
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	244-0806
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Hiroyasu Middle name Last name Shimada
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan
TEL	03-5459-5329
Homepage URL
Email	h.shimada@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

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	Aisei Hospital Ueno Clinic Research Ethics Committee
Address	2-18-6, Higashiueno, Taito-ku, Tokyo, Japan
Tel	03-6455-0880
Email	t.saito@ttc-smo.jp

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	医療法人健昌会　福島健康管理センター いきいきクリニック 稲葉眼科

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 13 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	30
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	2018 Year 06 Month 28 Day
Date of IRB	2018 Year 06 Month 28 Day
Anticipated trial start date	2018 Year 07 Month 17 Day
Last follow-up date	2019 Year 02 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 10 Day
Last modified on	2019 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038022