UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032604
Receipt number 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 2020/05/15 11:05:50

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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 Hiroshi
Middle name
Last name Kunugi

Organization

National Center of Neurology and Psychiatry

Division name

Department of Mental Disorder Research

Zip code

187-8502

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 Shintaro
Middle name
Last name Ogawa

Organization

National Center of Neurology and Psychiatry

Division name

Department of Mental Disorder Research

Zip code

187-8502

Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan

TEL

042-341-2711

Homepage URL


Email

sogawa@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



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

National Center of Neurology and Psychiatry Institutional Review Board

Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan

Tel

042-341-2711

Email

rinri-jimu@ncnp.go.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

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

72

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

2018 Year 03 Month 22 Day

Date of IRB

2018 Year 03 Month 14 Day

Anticipated trial start date

2018 Year 03 Month 29 Day

Last follow-up date

2020 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

2018 Year 05 Month 15 Day

Last modified on

2020 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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