A randomized, double-blind, placebo-controlled, parallel-group study to investigate the effect of continuous ingestion of Euglena gracilis EOD-1 strain on sleep in healthy adult men and women

A randomized, double-blind, placebo-controlled, parallel-group study to investigate the effect of continuous ingestion of Euglena gracilis EOD-1 strain on sleep - The effect of ingestion of Euglena gracilis EOD-1 strain on sleep

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000059358

Enrollment

Registered

2025-10-09

Start date

2025-10-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult men and women aged 20 to 69

Interventions

Two capsules containing 500 mg of microcrystalline cellulose instead of Euglena gracilis EOD-1 strain will be taken after dinner once a day for three weeks. Two capsules containing 500 mg of Euglena g

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy individuals Ages 20 and over and 69 and under Those who are aware of their sleep problems

Exclusion criteria

Exclusion criteria: 1. Subjects with a history of or current respiratory, digestive, hepatobiliary, pancreatic, hematological, renal, endocrine, or cardiovascular disease. 2. Subjects with a history of serious trauma or surgery within 12 weeks prior to the start of the study. 3. Subjects with a history or suspected food or drug allergies requiring treatment. 4. Subjects who, during the subject explanation, the principal investigator or co-researcher determines are regularly using supplements or health foods related to sleep quality. 5. Subjects who, during the subject explanation, the principal investigator or co-researcher determines are taking actions aimed at improving sleep, fatigue, or stress. 6. Subjects who experience nighttime awakenings due to nocturnal urination, etc. 7. Subjects who have been diagnosed with sleep apnea syndrome or chronic fatigue syndrome. 8. Subjects who are allergic to the test food. 9. Subjects who have participated in other clinical trials (including clinical trials) within 4 weeks prior to the start of the study. Other subjects who the principal investigator determines are unsuitable as subjects.

Design outcomes

Primary

Measure	Time frame
Sleep efficiency measured by actigraphy	—

Secondary

Measure	Time frame
1) Sleep onset latency measured by actigraphy 2) Number of awakenings measured by actigraphy 3) Five-factor OSA-MA questionnaire completed upon waking	—

Countries

Japan

Contacts

Public ContactSeiichiro Aoe

Otsuma Women's University Faculty of Home Economics, Department of Food Science

s-aoe@otsuma.ac.jp+81-3-5275-6048

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026