Clinical trial NCT06715475: A Verification Study to Evaluate the Safety of Long-term Consumption of the Test Food
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Japanese
Keywords: Plasmalogen
Safety
Sleep condition
Lead sponsor: Orthomedico Inc.
Sponsor class: OTHER
Collaborators: name: AOBA KASEI CO., LTD.
First posted: 2024-12-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Japanese
2. Men or women
3. Adults
4. Healthy individuals

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 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
4. 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
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
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

Primary outcomes:
measure: Number of individuals who experienced adverse events
timeFrame: Intervention period (up to 12 weeks)
Secondary outcomes:
measure: 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)
timeFrame: Week 6 and Week 12
measure: The measured values of blood plasmalogen levels at Week 6 and Week 12
timeFrame: Week 6 and Week 12
measure: The changes from baseline of blood plasmalogen levels at Week 6 and Week 12
timeFrame: Baseline, Week 6, and Week 12
measure: Each questionnaire item in the St. Mary's Hospital Sleep Questionnaire (SMH) at Week 6 and Week 12
timeFrame: Week 6 and Week 12
Other outcomes:
Locations:
city: Nerima-ku
country: Japan
facility: Nerima Medical Association Minami-machi Clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Medical Corporation Seishinkai, Takara Clinic
state: Tokyo
Study officials:
affiliation: Medical Corporation Seishinkai, Takara Clinic
name: Tsuyoshi Takara, MD
role: STUDY_CHAIR
References: