Healthy adults
Conditions
Interventions
Ingestion of research food for 12 weeks
Ingestion of placebo food for 12 weeks
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Subjects of men and women aged 20 to 64 (2) Subject who feel fatigue and mental fatigue due to the Uchida-Kraepelin performance test (3) 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 suffering from, undergoing treatment for, or with a history of diabetes mellitus, renal or hepatic disease, cardiac disease or other serious diseases, thyroid disease, adrenal disease, or other metabolic diseases. (2) Subjects who have a chronic disease and are currently undergoing treatment, have chronic fatigue syndrome (CFS), are receiving treatment for a sleep disorder, or for whom treatment is deemed necessary by the principal investigator or study investigator. (3) Subjects who reported having food allergies (especially gelatin) related to the test foods. (4) Subjects with a history of gastrointestinal diseases affecting digestion and absorption or gastrointestinal surgery (excluding appendicitis) (5) Subjects who regularly use medicines(includng herbal medicines) or quasi-drugs that my affect immunity, fatigue, oy sleep quality (6) Subjects who have a habit of consuming food products, healty foods(including foods for specified healty uses, functional foods, and supplements), or lactbacillus preparations containing a large amount of acetic acid bacteria (such as nigori vinegar), lactic acid bacteria, or bifidobacteria (such as lactic acid bacteria drinks, yogurt, kimchi) at least 3 times a week from the time of appliciation for study participation until the 12-week intake test day (7) Subjects who are unable to discontinue consumption of health food (including food for specifird health uses, food with functional claims, and supplements) and designated quasi-drugs during the study period (8) Subjects who work day and night shifts or engage in physical labor such as heavy lifting. (9) Subjects who habitually engage in strenuous sports such as marathon running during the test period (including professional athletes) and subjects on a diet (10) to (19) are listed in the "Other related information" column
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue survey using Visual Analogue Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality survey using OSA sleep inventory MA version | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness Support Co., Ltd. Clinical Trial Division
Outcome results
None listed