Unique ID issued by UMIN | UMIN000032604 |
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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 |
Effects of Plasmalogens on Psychological Symptoms in Healthy Men
Effects of Plasmalogens on Psychological Symptoms in Healthy Men
Effects of Plasmalogens on Psychological Symptoms in Healthy Men
Effects of Plasmalogens on Psychological Symptoms in Healthy Men
Japan |
Healthy
Adult |
Others
NO
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.
Efficacy
Confirmatory
Explanatory
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
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
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
20 | years-old | <= |
70 | years-old | >= |
Male
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
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
72
1st name | Hiroshi |
Middle name | |
Last name | Kunugi |
National Center of Neurology and Psychiatry
Department of Mental Disorder Research
187-8502
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
042-341-2711
hkunugi@ncnp.go.jp
1st name | Shintaro |
Middle name | |
Last name | Ogawa |
National Center of Neurology and Psychiatry
Department of Mental Disorder Research
187-8502
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
042-341-2711
sogawa@ncnp.go.jp
National Center of Neurology and Psychiatry
The Japanese Plasmalogen Society
Other
National Center of Neurology and Psychiatry Institutional Review Board
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
042-341-2711
rinri-jimu@ncnp.go.jp
NO
2018 | Year | 05 | Month | 16 | Day |
Unpublished
72
No longer recruiting
2018 | Year | 03 | Month | 22 | Day |
2018 | Year | 03 | Month | 14 | Day |
2018 | Year | 03 | Month | 29 | Day |
2020 | Year | 03 | Month | 31 | Day |
2018 | Year | 05 | Month | 15 | Day |
2020 | Year | 05 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034269
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