A Verification Study to Evaluate the Safety of Long-term Consumption of the Test Food

Orthomedico

Status: Active, not recruiting

Conditions: Healthy Japanese

Treatments: Dietary Supplement: Food containing plasmalogen; Dietary Supplement: Food not containing plasmalogen

Study type: Interventional

Funder types: Other

Identifiers

NCT06715475

04400-0006-06

Details and patient eligibility

About

This clinical study aims to verify the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The study will also exploratory assess blood plasmalogen levels and the effects of plasmalogen-containing food on sleep.

Full description

In this study, the investigators will confirm the safety of consumption of plasmalogen-containing food for 12 weeks in healthy Japanese. The investigators will also exploratory assess blood plasmalogen levels and the effect of plasmalogen-containing food on sleep conditions. The groups to be compared are plasmalogen-containing food and a placebo (plasmalogen-free food).

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Japanese
2. Men or women
3. Adults
4. Healthy individuals

Exclusion criteria

1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are undergoing medical treatment or have a medical history for any of the following diseases: mental disorder (such as depression), sleep apnea syndrome, hypersomnia, narcolepsy, insomnia, or valvular heart disease
5. Individuals who have habits of consuming foods or using devices to improve sleep
6. Individuals who have irregular sleeping habits due to lifestyle such as night shifts
7. Individuals who fall under the following sleeping conditions: sleeping in the same room with two or more people, living with preschool-aged children, living with individuals who require nursing care, or having their sleep potentially disturbed by the influence of others
8. Individuals who have nocturia two times or more
9. Individuals who usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)}
10. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
11. Individuals who are taking medications (including herbal medicines) or supplements
12. Individuals who are allergic to medicines or foods related to the test product
13. Individuals who are pregnant, lactating, or planning to become pregnant during this study
14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
15. Individuals who are judged as ineligible to participate in this study by the physician

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

24 participants in 2 patient groups, including a placebo group

Plasmalogen

Active Comparator group

Description:

Take 1 mg/day of plasmalogen

Treatment:

Dietary Supplement: Food containing plasmalogen

Placebo

Placebo Comparator group

Description:

Take 0 mg/day of plasmalogen

Treatment:

Dietary Supplement: Food not containing plasmalogen