UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030976 |
|---|---|
| Receipt number | 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 | 2020/04/13 08:36:27 |
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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
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
m.miyashita@waseda.jp
Sponsor or person
Institute
Waseda Univeristy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035367
