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

NCT06715475 | Active Not Recruiting DMC

• 1 other identifier: 04400-0006-06
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Japanese

Keywords

Plasmalogen; Safety; Sleep condition

Outcome Measures

Primary Outcomes (1)

• Number of individuals who experienced adverse events

  An adverse event is defined as the "development of a new abnormality" or "worsening" in physical signs, symptoms, etc. that is clinically meaningful to the study participant during the study period, and the investigator will evaluate the relationship between the adverse event and the test product.

  Intervention period (up to 12 weeks)

Secondary Outcomes (4)

• Number of individuals whose values of blood test and urinalysis are outside the reference range after intervention despite within the reference range at Baseline (before intervention)

  Week 6 and Week 12

• The measured values of blood plasmalogen levels at Week 6 and Week 12

  Week 6 and Week 12

• The changes from baseline of blood plasmalogen levels at Week 6 and Week 12

  Baseline, Week 6, and Week 12

• Each questionnaire item in the St. Mary's Hospital Sleep Questionnaire (SMH) at Week 6 and Week 12

  Week 6 and Week 12

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 not containing plasmalogen

Interventions

Food containing plasmalogen DIETARY_SUPPLEMENT

Take five capsules per day in the morning.

Plasmalogen

Food not containing plasmalogen DIETARY_SUPPLEMENT

Take five 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

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 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
• 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
• 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
• 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

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: November 22, 2024
• First Posted: December 4, 2024
• Study Start: December 2, 2024
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)