A Study to Verify the Sleep-improving Effects of the Test Food Consumption

NCT ID: NCT06907537

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2025-12-15

Brief Summary

The goal of this clinical trial is to test in Japanese adults who feel sleepy when they wake up. The question it aims to answer are:

•Does taking plasmalogens reduce sleepiness upon waking?

Participants will be given the following tasks:

• Take 4 capsules daily containing plasmalogens for 12 weeks.
• Answer the questionnaire on sleepiness1 when they wake up.
• Answer the questionnaire on daytime sleepiness2. Researchers will compare plasmalogens and placebo groups to see if plasmalogens reduce sleepiness upon waking.

Conditions

Healthy Japanese

Keywords

Plasmalogen; Sleep condition

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 four capsules per day in the morning.

Placebo

Take 0 mg/day of plasmalogen

Group Type: PLACEBO_COMPARATOR

Food without plasmalogen

Intervention Type: DIETARY_SUPPLEMENT

Take four capsules per day in the morning.

Interventions

Food containing plasmalogen

Take four capsules per day in the morning.

Intervention Type: DIETARY_SUPPLEMENT

Food without plasmalogen

Take four 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

5. Individuals whose Zc score of "sleepiness on rising" is relatively low at screening

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 of 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 of any of the following diseases: mental disorders (e.g., 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, or have a gelatin allergy or sea squirt-induced asthma

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

UMIN000057422

Identifier Type: REGISTRY

Identifier Source: secondary_id

04400-0010-16

Identifier Type: -

Identifier Source: org_study_id