Healthy subjects
Conditions
Interventions
Continuous intake of lactic acid bacterial beverages for 8 weeks
Continuous intake of control beverages for 8 weeks
Sponsors
EUPHORIA Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Healthy subjects aged 20-59 ?Subjects who have received a thorough explanation of the study, fully understand its contents, and voluntarily provide written informed consent (obtained via paper or electronic media) ?Subjects confirmed to be in good health based on pre-study screening assessments
Exclusion criteria
Exclusion criteria: ?Subjects who engage in regular exercise (defined as exercising at least twice a week for 30 minutes or more per session) ?Subjects with a BMI less than 18.5 kg/m2 or equal to or greater than 30.0 kg/m2 ?Subjects who have or have a history of serious diseases such as diabetes, liver disease, kidney disease, heart disease, or cardiovascular disorders ?Subjects with current illnesses under treatment or with a history of serious illnesses that required pharmacological treatment ?Subjects who have consumed fermented milk or lactic acid bacterial beverages at least twice a week during the 3 months prior to providing informed consent ?Subjects who have routinely taken over-the-counter medicines, quasi-drugs, or pharmacist-guided medicines for nutritional supplementation or anti-fatigue purposes during the 3 months prior to providing informed consent ?Subjects with a known allergy to dairy products or lactose intolerance ?Subjects who have participated in another clinical study within one month prior to providing informed consent, or who plan to participate in another clinical study after enrollment ?Subjects who are likely to change their lifestyle habits, including diet and exercise, during the study period ?Subjects deemed unsuitable for participation by the study physician based on questionnaire responses ?Subjects who plan to travel abroad, donate blood, become pregnant, or express breast milk during the study period ?Any other subjects deemed inappropriate for participation by the principal researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective fatigue (Web-based Daily Log Metrics) | — |
Secondary
| Measure | Time frame |
|---|---|
| [Secondary Outcomes] Wearable Device Metrics(Sleep score, sleep duration, sleep latency, wake time, total sleep time, REM sleep, light sleep, deep sleep, heart rate variability, resting heart rate, respiratory rate) Web-based Daily Log Metrics(Dizziness/lightheadedness, tinnitus, stiff shoulders, lower back pain, appetite, irritability, sensitivity to cold, general fatigue, motivation, mental clarity, satisfaction with sleep) Cognitive Task Performance Metrics(Total number of responses, number of correct responses, accuracy rate, weighted score (number of correct responses x accuracy rate) Heart Rate Variability Metrics(Heart rate (HR), RMSSD, SDNN, HF, LF, LF/HF ratio) Salivary Biomarkers(Cortisol, amylase) Profile of Mood States 2 (POMS2) Metrics(Anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, vigor-activity, friendliness, total mood disturbance (TMD) score) Visual Analog Scale (VAS) Metrics(Fatigue level) International Physical Activity Questionnaire (IPAQ) Metrics(Total physical activity, walking physical activity, moderate-intensity physical activity, vigorous-intensity physical activity, sedentary time) [Eligibility Confirmation and Safety Assessment Items] Anthropometric Measurements(Height, weight, body mass index (BMI)) Blood Test Parameters(White blood cell count, red blood cell count, hemoglobin (Hb), hematocrit, platelet count, total protein, albumin, blood urea nitrogen (BUN), creatinine, creatine kinase (CK), total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, total bilirubin, blood glucose, hemoglobin A1c) Blood Pressure Measurements(Systolic blood pressure, diastolic blood pressure) Self-Reported Questionnaire Items(Current medication use, type of occupation, lifestyle habits, willingness and understanding for participation in the study) Simplified Stress Checklist | — |
Countries
Japan
Contacts
Public Contactyuki Urushizawa
EUPHORIA Co., Ltd. Corporate Business Division
Outcome results
None listed