The verification study of improvements in psychological stress: a randomized double-blind, parallel-group, placebo-controlled trial
- Conditions
- Healthy Japanese adults
- Registration Number
- JPRN-UMIN000029582
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are pregnant, breast-feeding, and plan to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 8. Subjects who are judged as ineligible to participate in the study by the principal investigator 9. Subjects who have been diagnosed with Helicobacter pylori infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Autonomic function * Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform the test before and after psychological stress load.
- Secondary Outcome Measures
Name Time Method 1. Salivary amylase activity 2. Salivary cortisol activity 3. Pepsinogen I (PGI) 4. Pepsinogen II (PGII) 5. PGI/PGII 6. Profile of Mood States 2nd Edition (POMS2) Japanese version 7. Izumo Scale 8. Original questionnaires 8a. Visual Analogue Scale (VAS) 8b. Likert scale *1-6,8a Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform these assessments before and after psychological stress load. *7,8b Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform the assessment before psychological stress load.