Healthy
Conditions
Interventions
Two plasmalogen capsules will be administered daily (0.5 mg plasmalogens x 2) for three months
Two placebo capsules will be administered daily for three months
Sponsors
National Center of Neurology and Psychiatry
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShintaro Ogawa
National Center of Neurology and Psychiatry Department of Mental Disorder Research
Outcome results
None listed