UMIN-CTR Clinical Trial

Basic information
Public title	The effects of consuming Astaxanthin on reduction of physical fatigue as a result of exercise -A systematic review with Meta-analysis.
Acronym	A systematic review of consumption of Astaxanthin.
Scientific Title	The effects of consuming Astaxanthin on reduction of physical fatigue as a result of exercise -A systematic review with Meta-analysis.
Scientific Title:Acronym	A systematic review of consumption of Astaxanthin.
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether the effects of astaxanthin is effective in reducing physical fatigue as a result of exercise, compared with the intake of a placebo.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Autonomic nerve functions The outcomes are taken from guideline issued by the Japanese Society of Fatigue Science.
Key secondary outcomes	VAS (fatigue)

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
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Interventions/Control_2
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Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Participants: Healthy volunteers Intervention: Intake of food containing astaxanthin (dietary intake: 5~40 mg, period: 2~12 weeks) Comparison: Intake of placebo food Outcome: Primary; Autonomic nerve functions Key secondary; VAS (fatigue) Study design: Randomized, double-blind, placebo-controlled parallel group trial or randomized, double-blinded cross-over trial Literature targeting human clinical trials. The keywords used in the literature search will be in English or Japanese only.
Key exclusion criteria	Literature which does not match with PICOS will be excluded. Participants who are suffering from illness, planning or currently pregnant or breastfeeding, children (persons under 18 years), and those suffering chronic fatigue syndrome will be excluded from this study. Studies with subjects aged 18 or 19 may be subject to inclusion in the study if the number of such subjects is less than half of the total number of adults included in the study, and if approval of the Ethics Review Committee is gained. Foods which have special dosage forms or go through special digestion/ absorption pathway will be excluded.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Mika Middle name Last name Minamida
Organization	Maruzen Pharmaceuticals Co., Ltd.
Division name	Research & Development div.
Zip code	729-3102
Address	1089-8, Sagata, Shinnichi-cho, Fukuyama city, Hiroshima, Japan
TEL	0847-52-6262
Email	m-minamida@maruzenpcy.co.jp

Public contact
Name of contact person	1st name Mika Middle name Last name Minamida
Organization	Maruzen Pharmaceuticals Co., Ltd.
Division name	Research & Development div.
Zip code	729-3102
Address	1089-8, Sagata, Shinnichi-cho, Fukuyama city, Hiroshima, Japan
TEL	0847-52-6262
Homepage URL
Email	m-minamida@maruzenpcy.co.jp

Sponsor
Institute	Maruzen Pharmaceuticals Co., LTD.
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals Co., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Professor Hiroharu Kamioka, Tokyo University of Agriculture
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NA
Address	NA
Tel	-
Email	NA@NA

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

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 01 Day

Related information
URL releasing protocol	Contact details for inquiries: Mika Minamida (m-minamida@maruzenpcy.co.jp)
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	2020 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date	2020 Year 08 Month 01 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(Search) Searcher B will search 8 databases for studies from the beginning of each database to the search date. Reviewers A and C will search 3 internet search engines and journals which are in the possession of Maruzen Pharmaceuticals Co., Ltd. (Data extraction) In order to make the final selection of studies for the review, reviewers A and C will independently apply all criteria to the full text of articles that have passed the first eligibility screening. (Risk of bias assessment and Indirectness evaluation) Reviewers A and C will independently assess the quality of articles and evaluate the indirectness of articles. A full quality appraisal of these papers will be made using modified check list (12 items) from the Cochrane Handbook for interventional trials. Disagreement and uncertainties will be resolved by discussion with researcher D. (Imprecision assessment) Imprecision will be assessed based on the total number of participants in all included studies. (Inconsistency evaluation) 1: If there is only one eligible article, inconsistency will be evaluated as `unknown`. 2: Meta-analysis will not be performed when eligible literature's outcomes are not same. 3: If none of the above applies, heterogeneity will be evaluated according to a statistical test (the value of I2) based on the estimated effect value. When meta-analysis is not able to be performed, inconsistency will be evaluated according to rate of `significantly effective` articles. (Meta-analysis) Reviewers A and C will perform meta-analysis using RevMan 5 when no heterogeneity is found in multiple randomized controlled trials. (Protocol) The full protocol is archived at organization of the "Principal investigator". Please contact the "Contact person" directly for full details of the protocol.

Management information
Registered date	2020 Year 07 Month 27 Day
Last modified on	2020 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047078

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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