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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021812
Receipt No. R000023628
Scientific Title Study on effect of intake of tomato having high antioxidant activity on oxidative stress in vivo
Date of disclosure of the study information 2016/04/07
Last modified on 2018/07/02

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Basic information
Public title Study on effect of intake of tomato having high antioxidant activity on oxidative stress in vivo
Acronym Study on effect of intake of tomato having high antioxidant activity on oxidative stress in vivo
Scientific Title Study on effect of intake of tomato having high antioxidant activity on oxidative stress in vivo
Scientific Title:Acronym Study on effect of intake of tomato having high antioxidant activity on oxidative stress in vivo
Region
Japan

Condition
Condition Person whom oxidative stress in vivo is accelerated
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is the investigating reduction effect of oxidative stress in vivo by intake of tomato drink having high antioxidant activity. We compare the reduction effect of high carotenoids-containing tomato drink with that of low carotenoids-containing tomato drink when healthy subjects intake it for 4 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes SOAC (before intake and after 4 weeks intake)
Key secondary outcomes LAP, NEFA, Glycoalbumin, SOD, Oxidized LDL, 8-isoprostane in blood, HODE, ORAC, fasting blood sugar, HbA1C

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 The subjects intake 200 mL of tomato juice drink (high carotenoids-containing tomato drink) everyday for 4 weeks.
Interventions/Control_2 The subjects intake 200 mL of low carotenoids-containing tomato drink everyday for 4 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adults
Key exclusion criteria The person who is corresponding to following conditions is excluded from the subject in this study: minor, expectant and nursing mother, lactating woman, smoker, and be on medication.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Ukeda
Organization Kochi University
Division name Center for Regional Collaboration
Zip code
Address 2-17-14 Honmachi Asakura, Kochi, Japan-
TEL 088-844-8556
Email hukeda@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Ishizuka
Organization Kochi University
Division name Center for Regional Collaboration
Zip code
Address 2-17-14 Honmachi Asakura, Kochi, Japan
TEL 088-844-8556
Homepage URL
Email zuka@kochi-u.ac.jp

Sponsor
Institute Kochi University
Institute
Department

Funding Source
Organization Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor National Food Research Institute, National Agriculture and Food Research Organization
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 高知大学医学部、農学部、地域連携推進センター、国立研究開発法人 農業・食品産業技術総合研究機構 食品総合研究所

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 07 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
2015 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 01 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 04 Month 07 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023628

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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