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A study to evaluate the effects of the test food on improving fatigue sensation, sleep quality and cognitive function

A study to evaluate the effects of the test food on improving fatigue sensation, sleep quality and cognitive function - A study to evaluate the effects of the test food on improving fatigue sensation, sleep quality and cognitive function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048599
Enrollment
24
Registered
2022-08-05
Start date
2022-08-14
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 volunteers

Interventions

Sponsors

Japan Preventive Medicine Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Males and females whose age of 20 years or more and less than 65 years 2) Subjects who perceive fatigue sensation in daily work 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects with chronic fatigue syndrome (CFS) , or subjects deemed to have severe fatigue such as idiopathic chronic fatigue by the investigator 3) Subjects who take regularly medicines and quasi-drugs having the effects on fatigue sensation, sleep quality and cognitive function 4) Subjects who take regularly Food with Functional Claims having the effects on fatigue sensation, sleep quality and cognitive function 5) Subjects whose lifestyles are irregular because of night shift or others 6) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 7) Subjects who have the possibility of developing allergic symptoms by the test food 8) Subjects who are pregnant or lactating, or intending to become pregnant during the study 9) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 10) Subjects deemed unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
VAS (fatigue sensation)

Secondary

MeasureTime frame
VAS (eyestrain, sleepiness, motivation, concentration), Jikaku-sho shirabe, OSA sleep inventory MA version, The St. Mary's Hospital sleep questionnaire, Karolinska Sleepiness Scale Japanese version, POMS2 Japanese version, work performance, cognitive function test, autonomic nervous function, vascular state, sleep and activity tracker, urinalysis, blood analysis

Countries

Japan

Contacts

Public ContactTadakazu Takigami

Japan Preventive Medicine Inc. Research and Development

takigami@japanpm.com06-6831-3383

Outcome results

None listed

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