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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025373
Receipt No. R000029214
Scientific Title 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
Date of disclosure of the study information 2016/12/23
Last modified on 2017/12/23

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Basic information
Public title 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
Acronym A study for the effects of ingestion of food in adults with higher oxidative stress level and lower antioxidant ability
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Masami Sato
Organization WAKAMOTO PHARMACEUTICAL CO., LTD.
Division name Health Care Business Development Dept.
Zip code
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
1st name
Middle name
Last name Hiroyasu Shimada
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 23 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
2016 Year 12 Month 21 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000029214

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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