UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000038626