UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the effects of ingestion of food in adults with higher oxidative stress level and lower antioxidant ability : A randomized, double-blind, placebo controlled trial
Title of the study (Brief title)	A study for the effects of ingestion of food in adults with higher oxidative stress level and lower antioxidant ability
Region	Japan

Condition
Condition	Adults with higher oxidative stress level and lower antioxidant ability
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the effects of ingestion of food containing a plurality of components for 8 consecutive weeks on blood oxidative stress level, antioxidant ability, visual acuity and ocular tension in subjects with higher oxidative stress level and lower antioxidant ability
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	BAP Evaluate at points of 4-week and 8-week
Key secondary outcomes	d-ROMs, 8-OHdG, BAP/d-ROMs, Oxidative stress level, Endothelin, NO, visual acuity, ocular tension

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Food containing a plurality of components, twice a day for 8 weeks
Interventions/Control_2	Placebo without a plurality of components, twice a day for 8 weeks
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	40 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Men and women aged from 40 to 65 (2) higher oxidative stress level and lower antioxidant ability
Key exclusion criteria	(1)Subjects who regularly visit to ophthalmologic hospital for serious eye disease (2)Subjects who answered that there was a history of strength myopia in questionnaire (3)Subjects who received ophthalmic surgery within 3 months (4)Subjects who have a disease affecting the study results (e.g., cancer, hypertension, diabetes, amblyopia, autoimmune disease, thyroid dysfunction) (5) Subjects who have been taking foods affecting the study results once a week or more in the past month or expected to use once a week or more during study (6) Subjects who may have allergy to the test foods (7) Subjects who have a disease requiring regular medication or a history of serious diseases for which medication was required (8) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (9) Subjects who have participated in other clinical study within the last one month prior to the current study (10) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (11) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (12) Subjects who are judged as unsuitable by doctor for other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	Masami Sato
Organization	WAKAMOTO PHARMACEUTICAL CO., LTD.
Division name	Health Care Business Development Dept.
Address	2-2-2, Nihonbashi Honcho, Chuo-ku, Tokyo
TEL	03-3279-0387
Email	m.sato@wakamoto-pharm.co.jp

Public contact
Name of contact person	Hiroyasu Shimada
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	h.shimada@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	WAKAMOTO PHARMACEUTICAL 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

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 12 Month 24 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 22 Day
Last modified on	2017 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029214