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Anti-fatigue effects and safety of test food in healthy male and female participants presenting with fatigue in daily activities

Anti-fatigue effects and safety of test food in healthy male and female participants presenting with fatigue in daily activities:Randomized, placebo-controlled, double-blind, parallel-group comparison study - Anti-fatigue effects and safety of test food in healthy male and female participants presenting with fatigue in daily activities:Randomized, placebo-controlled, double-blind, parallel-group comparison study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047530
Enrollment
60
Registered
2023-07-13
Start date
2022-04-22
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 subjects

Interventions

Sponsors

Miura Clinic, Medical Corporation Kanonkai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy male and female subjects aged 40 to 64 years who are feeling daily fatigue (2) Subjects who do not have chronic fatigue syndrome (3) Subjects who have not been treated for sleep disorders (4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing

Exclusion criteria

Exclusion criteria: (1) Subjects with heart, liver, and kidney diseases (including complications of other diseases) (2) Subjects with a history of cardiovascular disease (3) Subjects with diabetes (4) Subjects with diseases currently being treated (5) Subjects who are allergic to food and drugs (6) Subjects with anemia symptoms (7) Subjects who go to the hospital for some illness or are treated with drugs and Chinese medicine (temporary administration is possible) (8) Subjects who play intense sports and subjects who are on a diet (9) Subjects with extremely irregular eating habits (10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (11) Subjects who drink more than 60 g of average daily pure alcohol (12) Subjects who smoke an average of 21 or more cigarettes a day (13) Subjects who are participating in or will participate in other clinical trials at the start of this study (14) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Design outcomes

Primary

MeasureTime frame
Subjective symptoms of QOL in daily life

Countries

Japan

Contacts

Public ContactMakoto Terashima

Oneness Support Co., Ltd. Clinical Trial Division

mterashima@oneness-sup.co.jp0648018917

Outcome results

None listed

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