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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033736
Receipt No. 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

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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
Email 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
Email y-nishizaki@tokai.ac.jp

Sponsor
Institute Tokai University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038470

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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