Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test product: Food containing lactic acid bacteria-fermented powder Administration: Take one tablet per day with water in the morning. *If you forget to take the test food, t
Sponsors
Arterio Bio Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who feel a temporary decline in vitality in daily life 6. Individuals whose standardized score (T score) of VA in POMS2 is between 30 and 50 at screening 7.Individuals who are judged as eligible to participate in the study by the physician according to the results of the Beck Depression Inventory 2nd Edition (BDI2) at screening
Exclusion criteria
Exclusion criteria: Individuals (who/whose) 1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, sleep disorder, drug dependence, or alcohol dependence 2.have a pacemaker or an implantable cardioverter defibrillator 3.are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4.have been diagnosed with chronic fatigue syndrome or sleep apnea syndrome 5.are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 6.are taking or using medications (including herbal medicines) or supplements 7.are allergic to medicines or foods related to the test product (particularly soy) 8.are pregnant, lactating, or planning to become pregnant during this study 9.have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 10.have a medical history of mental health issues 11.working form includes late-night shift or early-morning shift 12.feel their sleeping time is irregular 13.feel their lifestyle is irregular 14.live with infants (age <1) 15.sleep in the same room with children aged 1~5 16.take foods with a relaxing effect at least once a week 17.usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) 18.smoke >=20 cigarettes per day or who are unable to quit smoking from the time of waking up until the end of the test on the test day 19.work in physical labor 20.may engage in excessive intensity or volume of exercise during this study 21.wake up at night more than twice a week due to nocturia or other related factors 22.are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of Vigor-Activity (VA) in the Profile of Mood States 2nd Edition Japanese version (POMS2) at four weeks after intervention (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of Total Mood Disturbance (TMD), Anger-Hostility (AH), Confusion-Bewilderment (CB), Depression-Dejection (DD), Fatigue-Inertia (FI), Tension-Anxiety (TA), and Friendliness (F) in the POMS2 at 4w 2. The measured values of "sleepiness on rising," "initiation and maintenance of sleep," "frequent dreaming," "refreshing," "sleep length," and each item in the OSA sleep inventory MA version (OSA-MA) at 4w 3. The measured value of high-sensitivity C-reactive protein (hs-CRP) at 4w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed