UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on effect of intake of strawberry having high antioxidant activity on oxidative stress in vivo
Title of the study (Brief title)	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	Hiroyuki Ukeda
Organization	Kochi University
Division name	Center for Regional Collaboration
Address	2-17-14 Honmachi Asakura, Kochi, Japan-
TEL	088-844-8556
Email	hukeda@kochi-u.ac.jp

Public contact
Name of contact person	Satoshi Ishizuka
Organization	Kochi University
Division name	Center for Regional Collaboration
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023608