Healthy Japanese subjects
Conditions
Interventions
Duration: Four weeks Test beverage: Lactic acid bacteria-fermented milk drink Administration: Drink one bottle per day at any time during the day *Daily dose should be taken within the day. If yo
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who feel fatigue easily 6. Subjects whose the score of visual analogue scale (VAS) are relatively high at screening (before consumption) 7. Subjects who are judged as eligible to participate in the study by the physician
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who take dairy products every day 6. Subjects who have had problems due to taking dairy products. 7. Subjects who currently taking medications (including herbal medicines) and supplements 8. Subjects who are allergic to medicines and/or the test beverage related products 9. Subjects who are pregnant, lactation, or planning to become pregnant 10. Subjects who suffer from COVID-19 11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 12. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Subjective fatigue at four weeks after consumption (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective fatigue at two weeks after consumption (2w) 2. The measured value of each following items at 2w and 4w: each score of Profile of Mood States 2nd Edition (POMS2) Japanese version {Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), and Friendliness (F)}, each score of MOS Short-Form 36-Item Health. Survey (SF-36v2) {Physical Component Summary (PCS), Mental Component Summary (MCS), Role-social Component Summary (RCS), Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), Mental Herlth (MH)}, salivary cortisol, salivary chromogranin A, and each evaluation item in the autonomic function test {LF (low frequency), HF (how frequency), LF/HF ratio, average heart rate, maximum heart rate, minimum heart rate, TP (total power), ccvTP (coefficient of component variance TP), deviation value of autonomic function, and autonomic functional age} 3. Each items of POMS2 at 2w and 4w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed