Healthy adult
Conditions
Interventions
Ingestion of fermented plant extract for 4 consecutive weeks.
Ingestion of placebo for 4 consecutive weeks.
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healty men and women aged 18 to 64 years. (2)A lower salivary secretory immunoglobulin A secretion rate. (3)POMS2-AS gives priority to FI T score is high and VA T score is low. (4)Subjects with a bowel movement frequency of 3 to 5 times per week based on the results of lifestyle questionnare and subject with fatigue and dissatisfies with sleep in everyday life.
Exclusion criteria
Exclusion criteria: (1)Subjects who use fermented plant extract containing food or food similar to fermented plant extract. (2)Subjects routinely taking health supplements which may influence immune function. (3)Subjects routinely taking health supplements which may influence bowel movement. (4)Subjects taking medicine and quasi drug which may influence immune function. (5)Subjects undergoing treatment related to fatigue, stress, and/or sleep. (6)Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative. (7)who are under medication which may influence the outcome of the study. (8)Subjects having diseases affecting bowel movement or a history of these diseases. (9)Subjects who have a history of the allergic disease. (10)Subjects who have treated oral or dental care within the last one month prior to the current study or are planned to treat oral or dental care. (11)Subjects who have oral or dental problems with bleeding. (12)Night and day shift worker or manual laborer. (13)Subjects who have carried out an intense activity (14)Subjects who cannot carry out a procedure of various inspection by the rule during the study period. (15)Subjects who have a disease under treatment or are judged to that medical treatment are necessary by the doctor. (16)Subjects who have under treatment or a history of serious disease and disease to affect the adrenal cortical hormone secretion. (17)Subjects having possibilities for emerging allergy related to the study. (18)Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination. (19)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (20)Subjects who are Participating in other clinical studies at the beginning of the present study. (21)Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| salivary sIgA concentration, salivary s-IgA secretion rate, POMS2, stool frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| natural killer activity, OSA-MA, Analysis of the gut microbiota | — |
Countries
Japan
Contacts
Public ContactChiharu Goto
EP Mediate Co., Ltd. R&D Support Center, Foods Department
Outcome results
None listed