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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032229
Receipt No. R000036754
Scientific Title The effect of ingesting three dates a day on oxidative stress
Date of disclosure of the study information 2018/04/16
Last modified on 2019/04/15

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Basic information
Public title The effect of ingesting three dates a day on oxidative stress
Acronym The anti-oxidative effect of a small amount of dates
Scientific Title The effect of ingesting three dates a day on oxidative stress
Scientific Title:Acronym The anti-oxidative effect of a small amount of dates
Region
Japan

Condition
Condition Healthy male and female over 20 years old
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to verify the effect of ingesting a small amount of dates (three per day) on oxidative stress.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes oxidative stress markers
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of three dates a day for four weeks
Interventions/Control_2 Continue usual life for four weeks without ingesting dates
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Those who do not periodically take a medicine.
Key exclusion criteria Those who cannot ingest dates.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masanori
Middle name
Last name Ohta
Organization Fukuoka Womens University
Division name Department of Food and Health Sciences, International College of Arts and Sciences
Zip code 813-8529
Address 1-1-1 Kasumigaoka, Higashi-ku, Fukuoka 813-8529, Japan
TEL 092-661-2411
Email m-ohta@fwu.ac.jp

Public contact
Name of contact person
1st name Seiha
Middle name
Last name Harada
Organization Fukuoka Womens University
Division name Management Cotrol Center
Zip code 813-8529
Address 1-1-1 Kasumigaoka, Higashi-ku, Fukuoka 813-8529, Japan
TEL 092-661-2411
Homepage URL
Email soumu5@fwu.ac.jp

Sponsor
Institute Fukuoka Womens University
Institute
Department

Funding Source
Organization Fukuoka Womens University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukuoka Women's University
Address 1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
Tel 092-661-2411
Email soumu5@fwu.ac.jp

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
2018 Year 04 Month 16 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 32
Results
There was no effect of dates on the oxidative stress marker. However, the subjects who had exercise habit showed a decrease in percent fat and an increase in skeletal muscle mass by three dates a day for four weeks.
Results date posted
2019 Year 04 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 02 Month 08 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 03 Month 19 Day
Date of IRB
2018 Year 03 Month 02 Day
Anticipated trial start date
2018 Year 03 Month 19 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
2018 Year 06 Month 30 Day
Date trial data considered complete
2018 Year 06 Month 30 Day
Date analysis concluded
2019 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 13 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036754

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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