Healthy subjects
Conditions
Interventions
Test food intake for 4 weeks Washout (28 days or more ) Placebo food intake for 4 weeks
Placebo food intake for 4 weeks Washout (28 days or more ) Test food intake for 4 weeks
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and females who are between 20 and 60 years of age at the time of written informed consent. 2.Subjects who are aware of stress on a daily basis. 3.Subjects with the Beck Depression Inventory-II (BDI-II) score of < 20. 4.Subjects who are systolic blood pressure between 101 mmHg and 139 mmHg, and diastolic blood pressure between 61 mmHg and 89 mmHg. 5.Subjects who have a regular or part-time job. 6.Subjects 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 receiving medication or outpatient treatment for a serious disease. 2.Subjects receiving exercise or diet therapy under the supervision of a physician. 3.Subjects who may develop an allergy to the ingredient of the test food (rosemary) or aspirin. 4.Subjects with current or previous history of drug dependence or alcohol dependence. 5.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder. 6.Subjects who have extremely irregular life rhythms due to night work, shift work, etc. 7.Subjects whose eating, sleeping, and other habits are extremely irregular. 8.Subjects who are having a very unbalanced diet. 9.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more) or excessive smokers (21 cigarettes/day or more). 10.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases. 11.Subjects who use or are unable to stop using health foods, supplements (e.g., GABA, rosemary, caffeine, and theanine), and drugs that may affect stress. 12.Subjects who regularly drink energy drinks. 13.Subjects who anticipate a major change or stressful situation in their home or working environment (e.g., job change, move, marriage) from one month before screening to study completion. 14.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period. 15.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| State-Trait Anxiety Inventory | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Visual Analog Scale, salivary test (cortisol), heart rate variability (LF/HF) (Safety evaluation) Vital signs, physical measurements (body weight and BMI), biochemical test, hematology test, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactHiroyuki Miyazawa
HUMA R&D CORP Clinical Development Department
Outcome results
None listed