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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/04/13 |
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 |
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Condition | ||
Condition | Healthy | |
Classification by specialty |
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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 |
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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 |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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) | |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |