Study of the effect of a test food on feeling of tiredness
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000042933
- Lead Sponsor
- APO PLUS STATION CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 154
Not provided
Subjects (1)who take medicines, quasi-drugs, supplements, health foods, etc. more than 3 days a week (2)who cannot restrict the use of medicine or health foods that may influence their bowel movements after informed consent (3)visiting the hospital for diseases related to bowel movements and using drugs, or regularly using commercially available constipation medicine (4)who are under treatment or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, or heart disease) (5)currently undergoing treatment or with digestive diseases that affect the study or have a surgical history of digestive system (except appendicectomy) (6)with diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement, suspected of these diseases or have a history of these diseases (7)who drink alcohol over 1500 mL in terms of beer or smoke over average 20 cigarettes per day (8)who have a lifestyle that affect the result of this clinical trial (such as night shift worker or physical worker that carries heavy objects), or who plan to have such lifestyles during the test period (9)whose feeling of tiredness is caused by pain or suspected to be induced by pain (10)who are diagnosed with chronic fatigue syndrome or insomnia, or suspected of these diseases (11)who are diagnosed with sleep apnea syndrome or are suspected to have it (12)with a large fluctuation on defecation during menstruation or at poor physical condition (13)who have allergies to a specific drug or food (14)who have a feeling of tiredness caused by allergies to pollen, house dust, etc (15)who have participated in other clinical trial in the past one month, who have a plan to participate in other clinical trial during the test period (16)who are planned to become pregnant after submission of informed consent for this clinical trial or are pregnant or lactating (17)who are judged as unsuitable for this clinical trial by the investigator for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method fatigue VAS questionnaire
- Secondary Outcome Measures
Name Time Method sleep VAS questionnaire POMS2 OSA-MA intestinal flora (amplicon sequence analysis) faecal IgAs Plasma catecholamines 3 fractions