Effects of Plasmalogens on Psychological Symptoms in Healthy Me

Not Applicable

• Conditions: Healthy; D064368

• Registration Number: JPRN-jRCTs031180343
• Lead Sponsor: Kotaro Hattori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 72

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
We aim to assess the following factors at six weeks and three months after the start of the plasmalogen administration.<br><br>1. Amelioration of anxiety, sleep, and cognitive functions<br>2. Changes in plasmalogen levels in blood plasma, serum, and erythrocyte membranes<br>3. Changes in other biochemical parameters in the blood<br>4. Changes in salivary cortisol and immunoglobulin A levels