UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the influence of astaxanthin intake on physical performance and clinical data in male long distance runner
Title of the study (Brief title)	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	Nishizaki Yasuhiro
Organization	Tokai University School of Medicine
Division name	Dept. of Clinical Health Science
Address	143 Shimokasuya, Isehara, Kanagawa 259-1193
TEL	0463-93-1121
Email	y-nishizaki@tokai.ac.jp

Public contact
Name of contact person	Nishizaki Yasuhiro
Organization	Tokai University School of Medicine
Division name	Dept. of Clinical Health Science
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 07 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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