Elderly Individuals with Declining Cognitive Function and No Exercise Habits
Conditions
Interventions
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 t
Sponsors
Fujino Minoru
Fujino Takehiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy evaluation items (1) Cognitive function (2) Muscle strength (3) Immune function Safety evaluation items - Adverse events - Clinical tests | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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) | — |
Contacts
Public ContactEtsuko Kifuji
BOOCS Clinic Fukuoka
Outcome results
None listed