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NCT Number: NCT06715475

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Japanese

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nerima Medical Association Minami-machi Clinic, Nerima-ku, Tokyo, Japan

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Japanese
  • Men or women
  • Adults
  • Healthy individuals

Exclusion criteria

  • 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

Treatment and study plan

Food containing plasmalogen

Dietary Supplement

Take five capsules per day in the morning.

Food not containing plasmalogen

Dietary Supplement

Take five capsules per day in the morning.

Primary outcomes

  1. Number of individuals who experienced adverse events

    Time frame: Intervention period (up to 12 weeks)

    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.

Secondary outcomes

  1. 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)

    Time frame: Week 6 and Week 12

    Count the number of individuals whose values of blood test items (white blood cell count, red blood cell count, hemoglobin level, hematocrit value, platelet count, aspartate transaminase, alanine transaminase, γ-glutamyltransferase, total bilirubin, total protein, urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, serum amylase, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, glucose, and hemoglobin A1c levels) and urinalysis items (urinary protein, glucose, pH, and occult blood) are outside the reference range after intervention (Week 6 and Week 12) despite within the reference range at Baseline.

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

    Time frame: Week 6 and Week 12

    This is one of the exploratory assessment items. Approximately 3 mL of venous blood will be collected from each study participant, and this sample will be analyzed.

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

    Time frame: Baseline, Week 6, and Week 12

    This is one of the exploratory assessment items. Approximately 3 mL of venous blood will be collected from each study participant, and this sample will be analyzed.

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

    Time frame: Week 6 and Week 12

    These are one of the exploratory assessment items. The SMH is a self-administered tool to evaluate sleep over the past 24 hours. It includes questions with various response formats, such as yes/no answers, open-ended responses requiring specific time and time-of-day entries, and multiple-choice items with four or more options. Responses to the questions are reviewed individually.

Sponsors and collaborators

Lead sponsor

Orthomedico Inc.

Other

Collaborators

  • AOBA KASEI CO., LTD.

Registry information

Official study title

A Verification Study to Evaluate the Safety of Long-term Consumption of the Test Food: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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