UMIN-CTR Clinical Trial

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
Email	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
Email	amano@nichiyaku.ac.jp

Sponsor
Institute	Nihon Pharmaceutical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056493