Healthy adult
Conditions
Interventions
Ingestion of a drink containing lactic acid bacteria for 12 weeks
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)males and females from 20 to 64 years of age (2)Subjects who have a feeling of tiredness at the inspection before intervention (3)Subjects who are evaluated to have a low antioxidative activity from the result of d-ROMs and BAP value at the inspection before intervention (4)Subjects undergoing none of medical treatments (5)Subjects who have an ability to understand the purpose and contents of this clinical trial and voluntarily applied and agreed to participate in this clinical trial after the explanation of this clinical trial
Exclusion criteria
Exclusion criteria: (1)Subjects who take medicines, quasi-drugs, supplements, health foods, etc. (2)Subjects who cannot restrict the use of medicine or health foods that may influence their bowel movements after informed consent (3)Subjects who are under treatment or have a history of serious diseases (4)Subjects visiting the hospital for diseases related to bowel movements and using drugs, or regularly using commercially available constipation medicine (5)Subjects currently undergoing treatment or with digestive diseases that affect the study or have a surgical history of digestive system (except appendicectomy) (6)Subjects with diseases affecting bowel movement or have a history of these diseases (7)Subjects who drink alcohol over 1500 mL in terms of beer or smoke over average 20 cigarettes per day (8)Subjects who have a lifestyle that affect the result of this clinical trial or who plan to have such lifestyles during the test period (9)Subjects whose feeling of tiredness is caused by pain or suspected to be induced by pain (10)Subjects who are diagnosed with chronic fatigue syndrome or insomnia (11)Subjects who are diagnosed with sleep apnea syndrome or are suspected to have it (12)Subjects with a large fluctuation on defecation during menstruation or at poor physical condition (13)Subjects who have allergies to a specific drug or food (14)Subjects who have a feeling of tiredness caused by allergies to pollen, house dust, etc (15)Subjects 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)Subjects who are planned to become pregnant after submission of informed consent for this clinical trial or are pregnant or lactating (17)Subjects who are judged as unsuitable for this clinical trial by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antioxidative activity (d-ROMs, BAP, 8-OHdG), oxidative stress level defined as BAP/d-ROMs | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS questionnaire regarding feeling of tiredness, intestinal flora (amplicon sequence analysis) | — |
Countries
Japan
Contacts
Public ContactYuki Kitahara
APO PLUS STATION CO., LTD. CRO Department Clinical Operations Division
Outcome results
None listed