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A Preliminary Randomized Controlled Study on the Effects of Scallop-Derived Plasmalogens on Cognitive Function, Muscle Strength, and Immune Function in the Elderly

A Preliminary Randomized Controlled Study on the Effects of Scallop-Derived Plasmalogens on Cognitive Function, Muscle Strength, and Immune Function in the Elderly

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The plasmalogen group was composed of 16 men and 4 women with a mean age of 70.5 years, and the placebo group was composed of 15 men and 5 women with a mean age of 70.8 years.

A total of 83 candidate participants gave an informed consent and received a screening examination. With exclusion of 43 ineligible subjects, 40 eligible persons were randomized to either plasmalogen (n = 20) or placebo (n = 20) group. All of the randomized subjects completed the 8-week trial.

At least one episode of adverse event (AE) was reported by 4 persons in plasmalogen group and by 6 persons in placebo group. The AE episodes numbered 5 in plasmalogen group and 11 in placebo group. No serious AE was observed in either group. Two episodes in placebo group were classified as grade 2 in severity, and the others were classified as grade 1. One episode of diarrhea was judged to be causally related to plasmalogen use. The laboratory AE numbered 8 in plasmalogen group and 11 in placebo group. All but two (increased serum triglycerides of grade 2 in placebo group) were classified as grade 1.

Changes in outcome measurements from the baseline were analyzed by the linear regression or mixed model analysis to evaluate the effects of the 8-week intervention. Adjustment was made for sex, age class, and baseline value. The mixed model analysis was applied to variables with a 4-week measurement. A statistically significant between-group difference was not observed for outcomes of cognitive function (MoCA, WMS-R, and AD biomarkers), muscle function (gait speed, leg strength, and single-leg standing time), and immune function (CD4/CD8 ratio and IL12-p70). There were statistically significant improvements in A beta42/40 ratio and fast-walk gait speed in plasmalogen group, but not in placebo group. On the other hand, knee muscle strength improved in placebo, not plasmalogen, group. The was no between-group difference regarding the changes in secondary outcome measures (lymphocyte composition and blood plasmalogen levels).

A randomized placebo-controlled trial of old adults explored the effects of 8-week ingestion of plasmalogens (Pls) on cognitive, muscle, and immune function. 20 adults were assigned to Pls and placebo groups, and all completed the trial. A statistically significant between-group difference was noted for none of the outcomes. Statistically significant improvements in A beta42/40 ratio and fast-walk gait speed were noted in Pls, not placebo, group. An 8-week use of Pls (5 mg/day) was confirmed to be safe.

May. 22, 2026

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs031250052

Fujino Minoru

BOOCS Clinic Fukuoka

6-18, Tenyamachi, Hakata-ku, Fukuoka-shi

fujino-m@boocsclinic.com

Kifuji Etsuko

BOOCS Clinic Fukuoka

6-18, Tenyamachi, Hakata-ku, Fukuoka-shi

+81-92-283-6852

kifuji@boocsclinic.com

Complete

April. 18, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

(1) Men and women aged 65-80 at the time of consent
(2) Individuals planning to reside in an area within visiting distance for more than 6 months
(3) Individuals with a MoCA score of 21-25
(4) Individuals from whom written informed consent has been freely obtained regarding participation in the study
(5) Individuals who, at the time of consent, have been using medication and/or supplements at a stable dose for at least 3 months and are willing to continue using them at the same stable dose for the next 3 months

(1) Individuals with severe chronic diseases such as severe cardiovascular disease, end-stage renal disease, severe chronic obstructive pulmonary disease, or incurable terminal cancer.
(2) Individuals with physical disabilities that make it difficult to perform muscle strength tests.
(3) Individuals with chronic diseases that may affect cognitive function, such as Parkinson's disease or eating disorders.
(4) Individuals who are deemed inappropriate for this study by the principal investigator or co-investigators, such as those who have difficulty providing consent of their own free will due to dementia or other conditions.
(5) Individuals currently diagnosed with schizophrenia, depression, bipolar disorder, or other psychiatric disorders.
(6) Individuals with a history of acute illness or infection within 3 months prior to obtaining consent.
(7) Individuals diagnosed with brain organic lesions by brain MRI during screening.
(8) Individuals with unstable or poorly controlled diseases such as unstable angina, myocardial infarction within 6 months prior to obtaining consent, or poorly controlled diabetes or hypertension.
(9) Individuals who have undergone major surgery within 6 months prior to obtaining consent or who are scheduled for surgery during the study period.
(10) Individuals with a history of drug abuse or dependence.
(11) Individuals who have been enrolled in or participated in other clinical trials within 6 months prior to obtaining consent.
(12) Individuals with allergies to plasmalogen-containing products or shellfish.
(13) Individuals who have used plasmalogen-containing supplements in the past.
(14) Individuals with a regular exercise habit (engaging in 30 minutes or more of exercise at least two days a week).
(15) Individuals engaged in non-sedentary work such as standing jobs and carrying loads.

Both

Elderly Individuals with Declining Cognitive Function and No Exercise Habits

Plasmalogen Group: Participants will take two capsules of plasmalogen capsules (containing 2.5 mg of scallop-derived plasmalogen per capsule) daily for 8 weeks.
Placebo Group: Participants will take two capsules of placebo capsules daily for 8 weeks.

Efficacy evaluation items
(1) Cognitive function
(2) Muscle strength
(3) Immune function

Safety evaluation items
- Adverse events
- Clinical tests

- Plasma and red blood cell membrane plasmalogen concentrations
- Study feasibility (proportion of eligible subjects among those screened)
- Medication adherence (proportion of subjects who completed the study after allocation, proportion of subjects who took the medication)

+81-42-742-1130

Mar. 27, 2025

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