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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033352
Receipt No. R000038022
Official scientific title of the study Effect of supplement on contrast sensitivity : a pilot study
Date of disclosure of the study information 2018/07/13
Last modified on 2018/07/10

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Basic information
Official scientific title of the study Effect of supplement on contrast sensitivity : a pilot study
Title of the study (Brief title) 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 Kei Yui
Organization FANCL Corporation
Division name Research Institute, Health science research center
Address 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL 045-820-3755
Email ke-yui@fancl.co.jp

Public contact
Name of contact person Hiroyasu Shimada
Organization TTC Co.,Ltd.
Division name Clinical Research Planning Department
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 28 Day
Anticipated trial start date
2018 Year 07 Month 17 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
2018 Year 07 Month 10 Day
Last modified on
2018 Year 07 Month 10 Day


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

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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