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

NCT06907537 | Completed DMC

• 2 other identifiers: 04400-0010-16UMIN000057422
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The measured value of Zc score of "sleepiness on rising" in the OSA-MA after the 6-week intervention

  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

  After the 6 and12-week intervention

• The measured value of total score of the Athens Insomnia Scale (AIS) after the 6 and12-week intervention

  After the 6 and12-week intervention

Study Arms (2)

Plasmalogen

ACTIVE COMPARATOR

Take 1 mg/day of plasmalogen

Dietary Supplement: Food containing plasmalogen

Placebo

PLACEBO COMPARATOR

Take 0 mg/day of plasmalogen

Dietary Supplement: Food without plasmalogen

Interventions

Food containing plasmalogen DIETARY_SUPPLEMENT

Take four capsules per day in the morning.

Plasmalogen

Food without plasmalogen DIETARY_SUPPLEMENT

Take four capsules per day in the morning.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese
• Men or women
• Adults
• Healthy individuals
• Individuals whose Zc score of "sleepiness on rising" is relatively low at screening

You may not qualify if:

• Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
• Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
• 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
• 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
• Individuals who have habits of consuming foods or using devices to improve sleep
• Individuals who have irregular sleeping habits due to lifestyle such as night shifts
• 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
• Individuals who have nocturia two times or more
• 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)}
• Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
• Individuals who are taking medications (including herbal medicines) or supplements
• Individuals who are allergic to medicines or foods related to the test product, or have a gelatin allergy or sea squirt-induced asthma
• Individuals who are pregnant, lactating, or planning to become pregnant during this study
• 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
• Individuals who are judged as ineligible to participate in this study by the physician

Sponsors & Collaborators

• Orthomedico Inc.: lead
• AOBA KASEI CO., LTD.: collaborator

Study Sites (2)

Nerima Medical Association Minami-machi Clinic

Nerima-ku, Tokyo, 176-0002, Japan

Location

Medical Corporation Seishinkai, Takara Clinic

Shinagawa-ku, Tokyo, 141-0022, Japan

Location

MeSH Terms

Interventions

Food; Plasmalogens

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Phospholipid Ethers; Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Officials

• Tsuyoshi Takara, MD

  Medical Corporation Seishinkai, Takara Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 2, 2025
• Study Start: April 3, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)