Study of effects of test product on mental stress in healthy adults. -A randomized, double-blind, placebo-controlled, parallel-group study
- Conditions
- one(Healthy adults)
- Registration Number
- JPRN-UMIN000048949
- Lead Sponsor
- Kirin Holdings Company, Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 66
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Salivary cortisol
- Secondary Outcome Measures
Name Time Method Subjective evaluation