UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021811 |
|---|---|
| Receipt number | R000023608 |
| Scientific Title | Study on effect of intake of strawberry 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 14:35:16 |
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Basic information
Public title
Study on effect of intake of strawberry having high antioxidant activity on oxidative stress in vivo
Acronym
Study on effect of intake of strawberry having high antioxidant activity on oxidative stress in vivo
Scientific Title
Study on effect of intake of strawberry having high antioxidant activity on oxidative stress in vivo
Scientific Title:Acronym
Study on effect of intake of strawberry 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 strawberry drink having high antioxidant activity. We compare the reduction effect of strawberry drink with that of juice-free 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
ORAC (before intake and after 4 weeks intake)
Key secondary outcomes
LAP, NEFA, Glycoalbumin, SOD, Oxidized LDL, 8-isoprostane in blood, HODE, SOAC, 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 strawberry juice drink everyday for 4 weeks.
Interventions/Control_2
The subjects intake 200 mL of juice-free strawberry taste 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
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
zuka@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023608
