None(Healthy adults)
Conditions
Interventions
Intakes of test product for 8 days
Intakes of placebo product for 8 days
Sponsors
Kirin Holdings Company, Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Men and women aged between 20 and 60 at the time of obtaining consent to participate in the study. (2) Those who are judged to be healthy by the investigator and who do not have chronic physical illness. (3) Those who are prone to fatigue in daily life. (4) Those who feel stress, blush, heartbeat, etc. when speaking in front of people (5) Those who can come to the office on the designated inspection date and undergo inspection. (6) Those who have received sufficient explanation about the purpose and contents of this study, have the ability to consent, voluntarily apply for participation after understanding it well, and can consent to participate in this study in writing. (7) Those who the investigator deems appropriate to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Those who are receiving drug treatment, or regularly use drugs for purposes other than treating the disease. (2) Those who are suffering from, are undergoing treatment, or have a history of serious diseases such as diabetes, kidney/liver disease, heart disease, thyroid disease, adrenal disease, or other metabolic diseases. (3) Those who are undergoing treatment for psychological stress and using related or test product ingredient-containing medicines, supplements, and health foods. (4) Those who regularly take antihistamines. (5) Those who have been diagnosed with dry mouth or have subjective symptoms of it. (6) Those who have a score of 16 or higher on the Quick Inventory of Depressive Symptomatology. (7) Those who have been diagnosed with chronic fatigue syndrome, or are judged by the investigator or coordinator to have severe fatigue (8) Those who have a history of drug dependence, alcohol dependence, or their current medical history. (9) Those who may be allergic to the ingredients contained in the test food, and those who may be serious allergic to other foods and pharmaceuticals. (10) Persons with severe anemia. (11) Persons with BMI of less than 18.5 or more than 25 kg/m2. (12) Those who are expected to have a life event that is expected to have a significant psychological impact during the study period or have occurred. (13) Those who have a profession or experience in speaking in public. (14) Those who work for a company that develops, manufactures, and sells functional foods. (15) Smokers (16) Persons who cannot sleep at night due to irregular work or other reasons. (17) Those who are participating in or willing to participate in the study of ingesting foods, using drugs, applying cosmetics and drugs during this study period. (18) Those who are currently breastfeeding, are pregnant and may be pregnant, or are willing to become pregnant during the study period. (19) Others who are judged by the investigator to be unsuitable as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Salivary cortisol | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective evaluation | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co. Ltd Administrative Department of Clinical Trials
Outcome results
None listed