UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033736 |
|---|---|
| Receipt number | R000038470 |
| Scientific Title | A study for the influence of astaxanthin intake on physical performance and clinical data in male long distance runner |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2018/08/13 16:23:52 |
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Basic information
Public title
A study for the influence of astaxanthin intake on physical performance and clinical data in male long distance runner
Acronym
A study for the influence of astaxanthin intake on physical performance and clinical data in male long distance runner
Scientific Title
A study for the influence of astaxanthin intake on physical performance and clinical data in male long distance runner
Scientific Title:Acronym
A study for the influence of astaxanthin intake on physical performance and clinical data in male long distance runner
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the influence of astaxanthin intake on physical performance in male long distance runner and to examine the mechanism of action with the clinical data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
8 OHdG, isoprostane produce rate, high sensitivity CRP, exercise capacity, medical questionnaires (fatigue degree, etc.)
Key secondary outcomes
Physical performance, Record of activities and sleeping condition using wearable device, Physical examine, DXA examination, Blood test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Study food 8 weeks
Interventions/Control_2
Placebo food 8 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 23 | years-old | > |
Gender
Male
Key inclusion criteria
1)Healthy male students, freshman or sophomore who belong to the athletic club of Tokai University.
2)Age: 18 years old and over, less than 23 years old.
3)Individuals who do not undergo treatment of any disease and do not take any pharmaceuticals.
4)Drinking: within 20 g alcohol / day as the average of one week.
5)Individuals with ability of response to interview sheet.
6)Individuals who have data of the last medical checkup.
7)Individuals who sign the consent document after explanation of this study.
Key exclusion criteria
1)Individuals who undergo treatment or take pharmaceutical products.
2)Individuals with heart disease, kidney disease, diabetes, and other serious disorders.
3)Individuals who are deemed inappropriate as a study subject because of medical history of serious disorder.
4)Individuals with possibility of allergy caused by study.
5)Individuals who have unsteady lifestyle (including night shift and nocturnal study).
6)Individuals with drinking habit over 20 g alcohol/ day as the average of one week.
7)Individuals who do not refrain quasi-drugs and pharmaceuticals, and healthy foods (including supplement) during study period.
8)Individuals who have excess food which seems to affect on this study.
9)Individuals who do not take a test food as instructions during study period.
10)Individuals who do not fill out the diary.
11)Individuals who participate in other study, or had taken part in other study two month before this study, and the investigator deems inappropriate.
12)Individuals who the investigator deems inappropriate for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nishizaki Yasuhiro |
Organization
Tokai University School of Medicine
Division name
Dept. of Clinical Health Science
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193
TEL
0463-93-1121
y-nishizaki@tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nishizaki Yasuhiro |
Organization
Tokai University School of Medicine
Division name
Dept. of Clinical Health Science
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193
TEL
0463-93-1121
Homepage URL
y-nishizaki@tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AstaReal Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
東海大学医学部東京病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | 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 | 08 | Month | 13 | Day |
Last modified on
| 2018 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038470
