Healthy subjects
Conditions
Interventions
None listed
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and females who are aged 30 years or older and younger than 60 years at the time of written informed consent. 2.Subjects who completed high school or higher education. 3.Subjects whose BMI is 18.5 kg/m2 or more and less than 30 kg/m2. 4.People who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1.Subjects with symptoms of dementia or those previously diagnosed with dementia. 2.Subjects previously diagnosed with alcohol-related diseases or those being treated for such diseases. 3.Subjects with depressive symptoms or those previously diagnosed with depression. 4.Subjects who have previously had dysregulation of the hypothalamic-pituitary-adrenal axis. 5.Subjects on hormonal therapy or those previously diagnosed with menopausal by a physician. 6.Subjects with a history of gastrointestinal surgery (e.g., gastric resection). 7.Subjects with periodontitis or those being treated for periodontitis. 8.Subjects who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period. 9.Subjects who work night shifts or have an irregular life by working in night and day shifts during the study or those engaged in manual labor such as carrying heavy goods. 10.Vegetarian. 11.Smoking subjects or those who have stopped smoking within 12 months before the date of informed consent. 12.Subjects on brain function-related treatment or those prescribed associated medicine. 13.Subjects with sleep-related disorders such as sleep apnea syndrome, restless legs syndrome, or insomnia or those aware of having such disorders. 14.Subjects who have been taking any medicine or health food, including "food for specified health uses," "food with nutrient function claims," or "food with functional claims," containing any ingredients that may affect the study results once weekly or more often on a continuous basis (however, those able to stop taking the medicine/food upon providing informed consent and throughout the study are allowed to be included).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Questionnaire test (Japanese version of the Stress Mindset Measure, Coping Inventory for Stressful Situations-Japanese version, Japanese version of Somatosensory Amplification Scale, Emotion Regulation Questionnaire-Japanese version, Japanese version of the Perth Emotion Regulation Competency Inventory, Multidimensional Assessment of Interoceptive Awareness, The Cumulative Fatigue Symptoms Index, POMS 2-A short, State-TraitAnxietyInventory, Diagnostic of functional constipation, Diarrhea and loose stool questionnaire, Japanese version BDI-II, Japanese version of the Perceived Stress Scale, Stress Response Scale-18, Pittsburgh Sleep Quality Index-Japanese version, Visual Analog Scale) Fecal examination Blood test (inflammatory markers; IL-6, TNF-alpha, high-sensitivity CRP, IL-1beta) | — |
Countries
Japan
Contacts
Public ContactHidemasa Toya
HUMA R&D CORP Clinical Development Department
Outcome results
None listed