UMIN-CTR Clinical Trial

Basic information
Public title	The effects of pre-exercise antioxidant supplements on oxidative stress markers
Acronym	Exercise and antioxidant supplements
Scientific Title	The effects of pre-exercise antioxidant supplements on oxidative stress markers
Scientific Title:Acronym	Exercise and antioxidant supplements
Region	Japan

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

Objectives
Narrative objectives1	To examine the effects of pre-exercise supplements on subsequent oxidative stress parameters
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	d-ROMs, BAP
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	1) To take fasting blood samples 2) To consume anti-oxidant supplement 3) To cycle for 60 minutes at 75% of maximum oxygen uptake 4) To take further blood samples and subjective ratings of fatigue at immediately exercise, and 30, 60 and 90 min post-exercise
Interventions/Control_2	1) To take fasting blood samples 2) To consume placebo supplement 3) To cycle for 60 minutes at 75% of maximum oxygen uptake 4) To take further blood samples and subjective ratings of fatigue at immediately exercise, and 30, 60 and 90 min post-exercise
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	39 years-old >=
Gender	Male
Key inclusion criteria	1)Subjects who are aged 20-39 years old 2)Subjects who are males 3)Subjects who have no chronic diseases 4)Subjects who have no medication (including supplements) 5)Subjects who are non-smoker 6)Subjects who can perform exercise at designated exercise intensity and time 7)Subjects who were trying to lose weight in the last 3 months and are not going to lose weight during the study 8)Subjects who are not participating another study 9)Subjects who are able to take provided supplements - Subjects without a history of allergy
Key exclusion criteria	1)Subjects who are not aged 20-39 years old 2)Subjects who are females 3)Subjects who have chronic diseases 4)Subjects who have medication(including supplements) 5)Subjects who are smoker 6)Subjects who can not perform exercise at designated exercise intensity and time 7)Subjects who did lose weight in the last 3 months and are going to lose weight during the study 8)Subjects who are participating another study 9)Subjects who are not able to take provided supplements - Subjects with a history of allergy
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masashi Miyashita
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code
Address	2-579-15 Mikajima, Tokorozawa, Saitama
TEL	04-2947-6774
Email	m.miyashita@waseda.jp

Public contact
Name of contact person	1st name Middle name Last name Masashi Miyashita
Organization	Waseda University
Division name	Faculty of Sport Sciences
Zip code
Address	2-579-15 Mikajima, Tokorozawa, Saitama
TEL	04-2947-6774
Homepage URL
Email	m.miyashita@waseda.jp

Sponsor
Institute	Waseda Univeristy
Institute
Department

Funding Source
Organization	Waseda Univeristy
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
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	早稲田大学（埼玉県）/Waseda University（Saitama)

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 24 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	2018 Year 01 Month 01 Day
Date of IRB	2017 Year 10 Month 10 Day
Anticipated trial start date	2018 Year 01 Month 23 Day
Last follow-up date	2020 Year 03 Month 31 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 01 Month 24 Day
Last modified on	2020 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035367

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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