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

NCT06715475 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-04-01

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Food containing plasmalogen

Take five capsules per day in the morning.

DIETARY_SUPPLEMENT

Food not containing plasmalogen

Take five capsules per day in the morning.

Sponsors & Collaborators

  • AOBA KASEI CO., LTD.

    collaborator UNKNOWN

  • Orthomedico Inc.

    lead OTHER

Principal Investigators

  • Tsuyoshi Takara, MD · Medical Corporation Seishinkai, Takara Clinic

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-02
Primary Completion
2025-04-23
Completion
2025-04-23

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06715475 on ClinicalTrials.gov