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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032604
Receipt No. R000034269
Scientific Title Effects of Plasmalogens on Psychological Symptoms in Healthy Men
Date of disclosure of the study information 2018/05/16
Last modified on 2018/11/14

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Basic information
Public title Effects of Plasmalogens on Psychological Symptoms in Healthy Men
Acronym Effects of Plasmalogens on Psychological Symptoms in Healthy Men
Scientific Title Effects of Plasmalogens on Psychological Symptoms in Healthy Men
Scientific Title:Acronym Effects of Plasmalogens on Psychological Symptoms in Healthy Men
Region
Japan

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to evaluate the possible effects on depressed mood, anxiety, sleep, and cognitive functions in healthy men by administering a 1 mg daily dose of plasmalogens for three months.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Amelioration of depressed mood as evaluated by Beck Depression Inventory-Second Edition (BDI-II) at six weeks and three months after the start of plasmalogen administration
Key secondary outcomes We aim to assess the following factors at six weeks and three months after the start of the plasmalogen administration.

1. Amelioration of anxiety, sleep, and cognitive functions
2. Changes in plasmalogen levels in blood plasma, serum, and erythrocyte membranes
3. Changes in other biochemical parameters in the blood
4. Changes in salivary cortisol and immunoglobulin A levels

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 Treatment
Type of intervention
Food
Interventions/Control_1 Two plasmalogen capsules will be administered daily (0.5 mg plasmalogens x 2) for three months
Interventions/Control_2 Two placebo capsules will be administered daily for three months
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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male
Key inclusion criteria 1) Subjects who did not see a psychiatric doctor, did not receive psychological treatments, and did not take any psychotropic drugs within the past three months
2) Subjects whose body mass index (BMI) ranges from 18.5 to 29.9
3) Subjects who do not participate in any other clinical studies
Key exclusion criteria 1) Subjects with a history of drug or alcohol abuse
2) Subjects with a history of severe head injuries
3) Subjects with a history of severe internal diseases or severe injuries within the past three months
4) Subjects with a history of severe life events occuring within the past three months
5) Subjects with a shell food allergy
6) The lead researcher or collaborative researcher will determine those who are not eligible for this trial
Target sample size 72

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kunugi
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research
Zip code
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL 042-341-2711
Email hkunugi@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shintaro Ogawa
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research
Zip code
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL 042-341-2711
Homepage URL
Email sogawa@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization The Japanese Plasmalogen Society
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 05 Month 16 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 15 Day
Last modified on
2018 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034269

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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