UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050699 |
|---|---|
| Receipt number | R000057477 |
| Scientific Title | Effects of Chlorella intake on eyesight and cognitive function in young healthy men |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/28 14:44:00 |
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Basic information
Public title
Effects of Chlorella intake on eyesight and cognitive function in young healthy men
Acronym
Effects of Chlorella intake on eyesight and cognitive function
Scientific Title
Effects of Chlorella intake on eyesight and cognitive function in young healthy men
Scientific Title:Acronym
Effects of Chlorella intake on eyesight and cognitive function
Region
| Japan |
Condition
Condition
Healthy population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of Chlorella-derived multicomponent supplementation (12 weeks) on eyesight and cognitive function by conducting a double-blind, cross-over, randomized controlled trial in young healthy men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Before and after the 12-week intervention]
Cognitive function
Key secondary outcomes
[Before and after the 12-week intervention]
Eyesight, cerebral blood flow, body composition, blood chemistry parameters (e.g., plasma lutein concentration)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Chlorella intake: 6 g/day (as bulk powder), 15 tablets * 2 times/day, 12 weeks
Interventions/Control_2
Placebo intake: 7 g/day (maltodextrin), 15 tablets * 2 times/day, 12 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
| 24 | years-old | > |
Gender
Male
Key inclusion criteria
Corrected eyesight more than or equal to 1.0
Native language is Japanese
Key exclusion criteria
Current smoker
Currently taking Warfarin
A history or presence of ophthalmic diseases (except nearsightedness and astigmatism)
Current participation or intention to participate in other clinical trials
Considered ineligible judged by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Otsuki |
Organization
Ryutsu Keizai University
Division name
Faculty of Health and Sport Sciences
Zip code
301-8555
Address
120 Ryugasaki, Ibaraki, Japan
TEL
0297-64-0001
otsuki-takeshi@rku.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Suwabe |
Organization
Ryutsu Keizai University
Division name
Faculty of Health and Sport Sciences
Zip code
301-8555
Address
120 Ryugasaki, Ibaraki, Japan
TEL
0297-64-0001
Homepage URL
ksuwabe@rku.ac.jp
Sponsor or person
Institute
Ryutsu Keizai University
Institute
Department
Personal name
Funding Source
Organization
Sun Chlorella Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of Ryutsu Keizai University
Address
120 Ryugasaki, Ibaraki, Japan
Tel
0297-64-0001
tomwatanabe@rku.ac.jp
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
| 2023 | Year | 04 | Month | 01 | 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
| 2022 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057477
