UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041224 |
|---|---|
| Receipt number | 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 18:01:57 |
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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
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
m-minamida@maruzenpcy.co.jp
Sponsor or person
Institute
Maruzen Pharmaceuticals Co., LTD.
Institute
Department
Personal name
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
-
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047078
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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