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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033868
Receipt No. R000038626
Scientific Title Effects of fermented rice extract intake on endurance exercise performance in human
Date of disclosure of the study information 2018/08/23
Last modified on 2019/08/26

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Basic information
Public title Effects of fermented rice extract intake on endurance exercise performance in human
Acronym Effects of fermented rice extract intake on endurance exercise performance in human
Scientific Title Effects of fermented rice extract intake on endurance exercise performance in human
Scientific Title:Acronym Effects of fermented rice extract intake on endurance exercise performance in human
Region
Japan

Condition
Condition Healthy
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of constant fermented rice extract intake on endurance exercise performance (Aerobic work capacity) in trained male college athletes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximum oxygen consumption (estimate value) and anaerobic threshold during increment exercise test, and changes in blood lactate concentration and expiration gas parameters during constant exercise test.
Key secondary outcomes 1) Changes in blood glucose concentration during constant exercise test.
2) Changes in subjective fatigue parameters (VAS, POMS, stroop test, etc)
3) Changes in blood oxidative stress marker
4) Questionnaire about fatigue

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Subjects drink the fermented rice extract for 3 weeks (100 mL/day).
Interventions/Control_2 Subjects drink placebo for 3 weeks (100 mL/day).
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
19 years-old <=
Age-upper limit
30 years-old >
Gender Male
Key inclusion criteria 1) College students who belong to sports clubs.
2) Over 19-year-old
3) Male
4) Subjects who give consent in writing based on their own free will to attend this study after enough informed consent.
Key exclusion criteria 1) Subjects with a history of cardiovascular disease.
2) Subjects who get diseases and injured with inability to exercise during the experimental period.
3) Subjects who take drug, food, and equipment that affect the results of this study.
4) Subjects who judged inappropriate by the principal investigator or doctor.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kazumi
Middle name
Last name Masuda
Organization Kanazawa University
Division name Faculty of Human Sciences
Zip code 920-1192
Address Kakuma-machi, Kanazawa City, Ishikawa, Japan
TEL 076-264-5568
Email masudak@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Kazumi
Middle name
Last name Masuda
Organization Kanazawa University
Division name Faculty of Human Sciences
Zip code 920-1192
Address Kakuma-machi, Kanazawa City, Ishikawa, Japan
TEL 076-264-5568
Homepage URL
Email masudak@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Ishikawa Sunrise Industries Creation Organization
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Institute of Human and Social Sciences Ethics Committee, Kanazawa University
Address Kakuma-machi, Kanazawa City, Ishikawa, Japan
Tel 076-264-5450
Email n-somu@adm.kanazawa-u.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 08 Month 23 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 19
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
2018 Year 08 Month 10 Day
Date of IRB
2018 Year 07 Month 06 Day
Anticipated trial start date
2018 Year 08 Month 23 Day
Last follow-up date
2018 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 23 Day
Last modified on
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038626

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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