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A clinical study to evaluate the anti-fatigue effects of food material

A clinical study to evaluate the anti-fatigue effects of food material - A clinical study to evaluate the anti-fatigue effects of food material

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038259
Enrollment
20
Registered
2019-10-11
Start date
2019-10-12
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

Soiken 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 are aware of fatigue sensation in daily life 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 having the chronic fatigue syndrome(CFS), or subjects deemed to have severe fatigue like idiopathic chronic fatigue by the investigator 3) Subjects who go to a doctor about chronic diseases 4) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutrient replenishment in case of physical fatigue 5) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation 6) Subjects who have the possibility of developing allergic symptoms by the test food 7) 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) 8) 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 9) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 10) Subjects deemed unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
VAS(integral fatigue sensation, physical fatigue sensation and mental fatigue sensation)

Secondary

MeasureTime frame
VAS(perceived stress, tension, sleepiness, boredom, motivation, hunger sensation, thirstiness, jitteriness, refreshing feeling), POMS2 Japanese version, autonomic nervous function evaluation, work performance evaluation, blood analysis, urinalysis and stool analysis

Countries

Japan

Contacts

Public ContactShinichi Kashiwagi

Soiken Inc. R&D Division

kashiawgi_shnichi@soiken.com06-6871-8888

Outcome results

None listed

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