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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041224
Receipt No. R000047078
Scientific Title The effects of consuming Astaxanthin on reduction of physical fatigue as a result of exercise -A systematic review with Meta-analysis.
Date of disclosure of the study information 2020/10/01
Last modified on 2020/07/27

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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
Interventions/Control_1
Interventions/Control_2
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

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
Registered date File name

Research case data
Registered date File name


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