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

A Study to Verify the Sleep-improving Effects of the Test Food Consumption: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy Japanese
• Intervention / Treatment: Dietary supplement: Food containing plasmalogen; Dietary supplement: Food without plasmalogen

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Nerima-ku, Tokyo, Japan, 176-0002
      • Nerima Medical Association Minami-machi Clinic
    • Shinagawa-ku, Tokyo, Japan, 141-0022
      • Medical Corporation Seishinkai, Takara Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plasmalogen; Take 1 mg/day of plasmalogen	Dietary supplement: Food containing plasmalogen; Take four capsules per day in the morning.
Placebo Comparator: Placebo; Take 0 mg/day of plasmalogen	Dietary supplement: Food without plasmalogen; Take four capsules per day in the morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The measured value of Zc score of "sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA) after the 12-week intervention	The OSA-MA is used to assess sleep quality. Individuals are asked to complete the questionnaire immediately after waking on the examination day and two days before the examination. The raw scores from each examination day will be converted to Zc scores, and the three-day mean, rounded to one decimal place, will be used as the measured value. "Sleepiness on rising" consists of four questions. Higher score indicates better outcome.	After the 12-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The measured value of Zc score of "sleepiness on rising" in the OSA-MA after the 6-week intervention	The OSA-MA is used to assess sleep quality. Individuals are asked to complete the questionnaire immediately after waking on the examination day and two days before the examination. The raw scores from each examination day will be converted to Zc scores, and the three-day mean, rounded to one decimal place, will be used as the measured value. "Sleepiness on rising" consists of four questions. Higher score indicates better outcome.	After the 6-week intervention
The measured values of Zc score of "initiation and maintenance of sleep," "frequent dreaming," "refreshing," and "sleep length" in the OSA-MA after the 6 and12-week intervention	The OSA-MA is used to assess sleep quality. Individuals are asked to complete the questionnaire immediately after waking on the examination day and two days before the examination. The raw scores from each examination day will be converted to Zc scores, and the three-day mean, rounded to one decimal place, will be used as the measured value. "Initiation and maintenance of sleep" consists of five questions, "frequent dreaming" consists of two questions, "refreshing" consists of three questions, and "sleep length" consists of two questions. Higher scores indicate better outcomes.	After the 6 and12-week intervention
The measured value of total score of the Athens Insomnia Scale (AIS) after the 6 and12-week intervention	The AIS is used to assess sleep-related issues over the past month. Individuals are asked to answer eight sleep-related questions by selecting one of four response options, indicating experiences they have had at least three times per week in the past month. Lower score indicates better outcome.	After the 6 and12-week intervention

Collaborators and Investigators

• Sponsor: Orthomedico Inc.
• Collaborators: AOBA KASEI CO., LTD.
• Investigators: Study Chair: Tsuyoshi Takara, MD, Medical Corporation Seishinkai, Takara Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Plasmalogen; Sleep condition
• Additional Relevant MeSH Terms: Lipids; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Membrane Lipids; Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Phospholipid Ethers; Food; Plasmalogens
• Other Study ID Numbers: 04400-0010-16; UMIN000057422 (Registry Identifier: UMIN-CTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will be discussed among the research affiliates after the study is completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No