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Clinical research on the influence of plasmalogens and elastin containing food on cognitive function

Verification of safety and efficacy of plasmalogen and elastin combined formulation in cognitive function

189

Total participants (n=189). Placebo (n=63), plasmalogen (n=63), plasmalogen & elastin (n=63). Age as years old: 65 - 69: placebo (n=20), plasmalogen (n=25), plasmalogen & elastin (n=12), 70 - 74: placebo (n=18), plasmalogen (n=16), plasmalogen & elastin (n=26), 75 - 79: placebo (n=17), plasmalogen (n=10), plasmalogen & elastin (n=19), 80 or older: placebo (n=8), plasmalogen (n=12), plasmalogen & elastin (n=6).

Total participants: 189 enrolled and randomized. 63 plasmalogen & elastin group, 63 plasmalogen group, 63 placebo group. 3 discontinued (plasmalogen & elastin group: 2 withdrew consent, placebo group: 1 withdrew consent). 16th week-completed participants: 186 (plasmalogen & elastin group: 61 analysis object, plasmalogen group: 63 analysis object, placebo group: 62 analysis object). There was no seriously diseased participant.

There was no case reported for any diseases

In the stratified analysis of participants with the screening total score between 6 and 9(RBMT),the screening total score of RBMT in the plasmalogens & elastin group was higher than placebo group. (plasmalogens & elastin group:1.85+-1.66, plasmalogens group:0.67+-2.03,placebo group: 0.61+-1.75,plasmalogens & elastin group; placebo group p=0.05). Furthermore, in the stratified analysis of participants with more than 2.9 of AGE value,the lower scale orientation score in RBMT was significantly higher in the plasmalogens & elastin group than in the placebo group. (plasmalogens & elastin group: 0.11+-0.33, plasmalogens group:0.11+-0.33, placebo group: -0.501+-0.53,plasmalogens & elastin group; placebo group p=0.01). In the stratified analysis of participants with the screening total score of RBMT less than 6, the score of physical functioning (PF) in SF-36 was significantly higher in the plasmalogens & elastin group than in the placebo group. (plasmalogens & elastin group: 5.71+-8.38, plasmalogens group: 0.71+-8.86, placebo group: -9.38+-7.76, plasmalogens & elastin group; placebo group p=0.01).

Plasmalogens and elastin containing food showed no significant efficacy for the improvement of cognitive function in total number of healthy elderly subjects (over 65 years old) participated in the present study, but it improved significantly the cognitive function in such subjects who showed mild memory impairment and forgetfulness.

Mar. 01, 2023

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs041210012

Ono Ken

Izu Health & Medical Center

270-1 Takyou,Izunokuni, Shizuoka

kenken@izu-hmc.ecnet.jp

Yamada Shizuo

Center for Pharma-Food Research , Graduate School of Pharmaceutical Sciences, University of Shizuoka

52-1 Yada, Suruga-ku, Shizuoka

+81-54-264-5625

yamada@u-shizuoka-ken.ac.jp

Complete

April. 23, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

health services research

1) The subjects who are Male and Femaile over 65 who are aware of forgetfulness.
2) The subjects who displayed 24 scores or more of MMSE-J

1) The subjects who are likely to have allergy symptoms due to test ingredients.
2) The subjects who were diagnosed as patients with dementia
3) The subjects who received surgical operation for stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, cerebral contusion injury Head trauma Those with the inpatient surgery.
4) The subjects with medical history of epilepsy or diabetes and/or receiving medical treatment presently.
5) The subjects who is taking medicines (antipsychotic drugs, anxiolytics, antidepressants, antiparkinsonian drugs, antidepressants, antiepileptic drugs

Both

subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage,

To evaluate cognitive function improvement effect of combined formulation of plasmalogens and elastin containing food for forgetful and dementia preliminary forces

Japanese version of River Mead Behavior Memory Test

Clinical Assessment for Attention-Visual Cancellation Task, MOS 36-Item Short-Form Health Survey, AGE Reader-Advanced Glycation End-products,

+81-53-435-2680

April. 06, 2021

none