UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055075 |
|---|---|
| Receipt number | R000062907 |
| Scientific Title | A systematic review of the antioxidant effects of Astaxanthin on blood lipids |
| Date of disclosure of the study information | 2024/07/25 |
| Last modified on | 2024/07/25 17:45:07 |
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Basic information
Public title
A systematic review of the antioxidant effects of Astaxanthin on blood lipids
Acronym
A systematic review of the antioxidant effects of Astaxanthin on blood lipids
Scientific Title
A systematic review of the antioxidant effects of Astaxanthin on blood lipids
Scientific Title:Acronym
A systematic review of the antioxidant effects of Astaxanthin on blood lipids
Region
| Japan |
Condition
Condition
Healthy adults who were not suffering from any diseases (excluding those under 18, pregnant women, and lactating women)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the antioxidant effect of blood lipids by astaxanthin intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is inhibition of blood lipid oxidation, especially as an indicator of the oxidation state of blood lipids such as phospholipid hydroperoxide (PLOOH), malondialdehyde (MDA), and isoprostane (ISP)).
Key secondary outcomes
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
A systematic literature search is performed through scientific and clinical trial registries databas
Participants (P): Healthy adults who were not suffering from any diseases (excluding those under 18, pregnant women, and lactating women).
Intervention (I): Intake of foods (tablets, capsules, granules, beverages, processed foods) containing astaxanthin. compositions that also contain ingredients other than Astaxanthin as test substances are excluded.
Astaxanthin intake should be 0.4-30 mg/day.
Comparison (C): The comparison group is set up as consuming a placebo food that does not contain Astaxanthin.
Outcome(O): The primary outcome is inhibition of blood lipid oxidation , especially as an indicator of the oxidation state of blood lipids such as phospholipid hydroperoxide (PLOOH), malondialdehyde (MDA), and isoprostane (ISP)).
Study design (S): Randomized, quasi-randomized, and non-randomized controlled trials (parallel group or crossover controlled trials) will be included.
Key exclusion criteria
Studies which do not meet the key inclusion criteria will be excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Seki |
Organization
FUJIFILM Corporation
Division name
Consumer Healthcare Business Div.
Zip code
106-8620
Address
26-30, Nishiazabu 2-chome, Minato-ku, Tokyo, Japan
TEL
08013399052
shinobu.seki@fujifilm.com
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Saito |
Organization
FUJIFILM Corporation
Division name
FUJIFILM Corporation
Zip code
106-8620
Address
26-30, Nishiazabu 9-chome, Minato-ku, Tokyo, Japan
TEL
08021194836
Homepage URL
hitomi.saito@fujifilm.com
Sponsor or person
Institute
FUJIFILM Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yakujihou Marketing Jimusho Co., Ltd.
Name of secondary funder(s)
N/A
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
None
None
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
| 2024 | Year | 07 | Month | 25 | 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
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research review will be conducted in accordance with PRISMA2020.
Management information
Registered date
| 2024 | Year | 07 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062907
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/07/25 | 研究プロトコル_アスタキサンチン_血中脂質の抗酸化_240725.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
