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An exploratory study examining the effect of ONR-9 on fatigue in healthy adults: A randomized, double-blind, placebo-controlled, cross-over study.

An exploratory study examining the effect of ONR-9 on fatigue in healthy adults: A randomized, double-blind, placebo-controlled, cross-over study. - the effect of the test food on fatigue

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024337
Enrollment
30
Registered
2017-12-17
Start date
2016-10-08
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

None

Interventions

Intake of test food for a week, then intake of placebo for a week after 2-week wash out period. Intake of placebo for a week, then intake of test food for a week after 2-week wash out period.

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) healthy males and females 2) subjects who have normal breath gas response by oral administration of the test food.

Exclusion criteria

Exclusion criteria: 1) subjects who have allergy to medicinal and foods. 2) subjects who have a severe past medical history, acute infection, or mental disorder. 3) subjects who will have stressful situation in the intake periods. 4) subjects who smoke more than 20 cigarettes a day. 5) subjects who take alcohol nearly every day. 6) subjects who take much caffeine rich drink. 7) shift wokers and graveyard shift. 8) subjects who routinely take medicin, supplements, FOSHU, and/or health food which affect to the result of the study. 9) subjects who are estimated inappropriate to participate to this study by principal investigator.

Design outcomes

Primary

MeasureTime frame
Cognitive task performance

Secondary

MeasureTime frame
Mental task performance Autonomic balance Blood fatigue-related biomarkers VAS (fatigue) POMS SF-36

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

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