NCT06715475

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Orthomedico Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Japanese

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-02
• Primary completion: 2025-04-23
• Completion: 2025-04-23
• First posted: 2024-12-04
• Last updated: 2025-04-01

Locations

2 sites across 1 country: Japan