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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021997
Receipt No. R000025349
Scientific Title Anti-Fatigue Effect of NIHONSYOKU: Cross-Over Study
Date of disclosure of the study information 2016/04/20
Last modified on 2016/08/10

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Basic information
Public title Anti-Fatigue Effect of NIHONSYOKU: Cross-Over Study
Acronym Anti-Fatigue Effect of NIHONSYOKU
Scientific Title Anti-Fatigue Effect of NIHONSYOKU: Cross-Over Study
Scientific Title:Acronym Anti-Fatigue Effect of NIHONSYOKU
Region
Japan

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Estimation of anti-fatigue effect of NIHONSYOKU.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective fatigue degree
Autonomic nervous function
Cognitive function
Oxidation stress
Antioxidant activity
Key secondary outcomes Amount of activity
Other biochemical tests

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of a test meal for dinner for 2-4 weeks.
Interventions/Control_2 Ingestion of a placebo meal for dinner for 2-4 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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Healthy persons who are aged from 18 to 79 years.
2.Persons who are not shift worker.
Key exclusion criteria 1.Persons who are in treatment.
2.Persons who have medical history of cardiovascular disease such as arrhythmia and angina pectoris, etc.
3.Persons who have autonomic nervous system dysfunction.
4.Persons who have medical history of nervous system disease such as unconsciousness, coma, and convulsion, etc.
5.Persons who have insomnia.
6.Persons who have food allergy.
7.Persons who are heavy user of alcohol.
8.Persons whose body mass index is less than 17 and more than 31.
9.Persons who are on a diet.
10.Pregnant women.
11.Persons who are judged not suitable to participate in this trial by investigators.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyoshi Watanabe
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
Address 9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL 06-6485-0288
Email chsi-b@ado.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Mizuno
Organization Osaka City University
Division name Center for Health Science Innovation
Zip code
Address 9F, Tower-C, Knowledge Capital, Grand Front Osaka, 3-1 Ofuka-cho, Kita-ku, Osaka 530-0011, Japan.
TEL 06-6485-0288
Homepage URL
Email chsi-b@ado.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Center for Health Science Innovation
Institute
Department

Funding Source
Organization MAFF(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 大阪市立大学健康科学イノベーションセンター
Osaka City University Center for Health Science Innovation

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 20 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 04 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 17 Day
Last follow-up date
2015 Year 12 Month 13 Day
Date of closure to data entry
2016 Year 02 Month 26 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 20 Day
Last modified on
2016 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025349

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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