UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029138
Receipt number R000033316
Scientific Title Antioxidant intake from a traditional Japanese-style diet
Date of disclosure of the study information 2017/09/14
Last modified on 2017/09/14 09:28:14

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Basic information

Public title

Antioxidant intake from a traditional Japanese-style diet

Acronym

ORAC validation study in Japan

Scientific Title

Antioxidant intake from a traditional Japanese-style diet

Scientific Title:Acronym

ORAC validation study in Japan

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the high contributors to antioxidant capacity intake from the overall diet of the Japanese population.

Basic objectives2

Others

Basic objectives -Others

To construct a hydrophilic (H-) and lipophilic (L-) antioxidant capacity database of foods representative of the typical Japanese diet using the H-/L- oxygen radical absorbance capacity method.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

hydrophilic and lipophilic antioxidant capacity

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Not applicable

Key exclusion criteria

Not applicable

Target sample size

113


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Megumi Tsubota-Utsugi

Organization

Iwate Medical University School of Medicine

Division name

Department of Hygiene and Preventive Medicine

Zip code


Address

2-1-1 Nishitokuda, Yahaba-cho, Shiwa-gun, Iwate 028-3694, Japan

TEL

019-651-5111

Email

mutsugky@iwate-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Megumi Tsubota-Utsugi

Organization

Iwate Medical University School of Medicine

Division name

Department of Hygiene and Preventive Medicine

Zip code


Address

2-1-1 Nishitokuda, Yahaba-cho, Shiwa-gun, Iwate 028-3694, Japan

TEL

019-651-5111

Homepage URL


Email

mutsugky@iwate-med.ac.jp


Sponsor or person

Institute

The Ministry of Education, Culture, Sports, Science, and Technology, Japan

Institute

Department

Personal name



Funding Source

Organization

the Ministry of Education, Culture, Sports, Science, and Technology, Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2017 Year 09 Month 14 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

The traditional Japanese diet, characterized by the high intake of tea, rice, seafood, and soybean products, might be considered optimal for high antioxidant capacity intake.

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

2009 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 07 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Commonly consumed foods were estimated using 3-day DRs over the four seasons among 55 men and 58 women in Japan. These dietary records were gathered by voluntary participants in 1996 and 1997.


Management information

Registered date

2017 Year 09 Month 14 Day

Last modified on

2017 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033316


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name