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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030976
Receipt No. R000035367
Scientific Title The effects of pre-exercise antioxidant supplements on oxidative stress markers
Date of disclosure of the study information 2018/01/24
Last modified on 2018/07/12

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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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 23 Day
Last follow-up date
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
2018 Year 07 Month 12 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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