UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049617 |
|---|---|
| Receipt number | R000056493 |
| Scientific Title | A Study on Subjective Evaluation of Fatigue Tolerance in Mental Stress after Long-Term Intake of Supplements Containing Plasmalogen (HSOP; Hokkaido Scallop Oil Plasmalogen) |
| Date of disclosure of the study information | 2022/11/26 |
| Last modified on | 2022/11/26 13:14:08 |
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Basic information
Public title
The effect of fatigue reduction after the intake of plasmalogen supplement.
Acronym
The intake of plasmalogen supplement.
Scientific Title
A Study on Subjective Evaluation of Fatigue Tolerance in Mental Stress after Long-Term Intake of Supplements Containing Plasmalogen (HSOP; Hokkaido Scallop Oil Plasmalogen)
Scientific Title:Acronym
The intake of plasmalogen supplement.
Region
| Japan |
Condition
Condition
healthy adult men and women at 18 to 60 years old.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Studies have reported the effects of plasmalogen on improvement of memory function in the elderly. This time, we will examine the subjective evaluation of fatigue resistance in mental stress from mental arithmetic task by ingesting a supplement containing this plasmalogen as the main ingredient for 3 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After 14 days, 28 days, 42 days, 56 days, and 70 days from the start, the Uchida-Kraepelin test was performed as a mental stress. After that, POMS and VAS are performed as subjective evaluations to evaluate mental fatigue and stress tolerance.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
The group taking the plasmalogen supplement takes 2 capsules once a day. The intake period should be 70 days, and should be taken after breakfast.
Interventions/Control_2
The group taking the placebo supplement takes 2 capsules once a day. The intake period should be 70 days, and should be taken after breakfast.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women between the ages of 18 and 60.
Key exclusion criteria
Those with food allergies and those taking medications.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Umon |
| Middle name | |
| Last name | Agata |
Organization
Nihon Pharmaceutical University
Division name
Department of Pharmacy
Zip code
362-0806
Address
Saitama-ken, Kitaadati-gun, Ina-machi, Komuro10281
TEL
048-721-1155
u-agata@nichiyaku.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Amano |
Organization
Nihon Pharmaceutical University
Division name
Shomu
Zip code
362-0806
Address
Saitama-ken, Kitaadati-gun, Ina-machi, Komuro10281
TEL
048-721-1155
Homepage URL
amano@nichiyaku.ac.jp
Sponsor or person
Institute
Nihon Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
VENEX Co., Ltd
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
Nihon Pharmaceutical University ethics committee
Address
Saitama-ken, Kitaadati-gun, Ina-machi, Komuro10281
Tel
048-721-1155
t-yamada@nichiyaku.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
| 2022 | Year | 11 | Month | 26 | 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
40
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 11 | Month | 26 | Day |
Last modified on
| 2022 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056493
