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

NCT ID: NCT06715475

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-04-23

Brief Summary

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.

Detailed 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).

Conditions

Healthy Japanese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Plasmalogen

Take 1 mg/day of plasmalogen

Group Type: ACTIVE_COMPARATOR

Food containing plasmalogen

Intervention Type: DIETARY_SUPPLEMENT

Take five capsules per day in the morning.

Placebo

Take 0 mg/day of plasmalogen

Group Type: PLACEBO_COMPARATOR

Food not containing plasmalogen

Intervention Type: DIETARY_SUPPLEMENT

Take five capsules per day in the morning.

Interventions

Food containing plasmalogen

Take five capsules per day in the morning.

Intervention Type: DIETARY_SUPPLEMENT

Food not containing plasmalogen

Take five capsules per day in the morning.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AOBA KASEI CO., LTD.

UNKNOWN

Sponsor Role: collaborator

Orthomedico Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsuyoshi Takara, MD

Role: STUDY_CHAIR

Medical Corporation Seishinkai, Takara Clinic

Locations

Nerima Medical Association Minami-machi Clinic

Nerima-ku, Tokyo, Japan

Medical Corporation Seishinkai, Takara Clinic

Shinagawa-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

04400-0006-06

Identifier Type: -

Identifier Source: org_study_id