UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057607 |
|---|---|
| Receipt number | R000065794 |
| Scientific Title | Effect of lactic acid bacterial beverage consumption on the reduction of summer fatigue: Randomized controlled trial |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2026/10/15 12:42:40 |
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Basic information
Public title
Effect of lactic acid bacterial beverage consumption on the reduction of summer fatigue
Acronym
Effect of lactic acid bacterial beverage consumption on the reduction of summer fatigue
Scientific Title
Effect of lactic acid bacterial beverage consumption on the reduction of summer fatigue: Randomized controlled trial
Scientific Title:Acronym
Effect of lactic acid bacterial beverage consumption on the reduction of summer fatigue: Randomized controlled trial
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether consuming lactic acid bacterial beverages reduces summer fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective fatigue (Web-based Daily Log Metrics)
Key secondary outcomes
[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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of lactic acid bacterial beverages for 8 weeks
Interventions/Control_2
Continuous intake of control beverages for 8 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key 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
Key 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
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Takahashi |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Business Division
Zip code
102-0083
Address
10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-6388-9260
ryosuke.takahashi@eu-phoria.jp
Public contact
Name of contact person
| 1st name | yuki |
| Middle name | |
| Last name | Urushizawa |
Organization
EUPHORIA Co., Ltd.
Division name
Corporate Business Division
Zip code
102-0083
Address
10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo, Japan
TEL
03-6388-9260
Homepage URL
yuki.urushizawa@eu-phoria.jp
Sponsor or person
Institute
EUPHORIA Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
NISSIN YORK CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
https://doi.org/10.3390/jcm15114175
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3390/jcm15114175
Number of participants that the trial has enrolled
171
Results
Web-based subjective fatigue (primary outcome) showed no significant between-group difference. The lactic acid bacteria beverage group had significantly shorter sleep onset latency and lower pre-task VAS fatigue than the control group. During tasks, this group showed a greater LF/HF increase, followed by a greater LF/HF decrease and HF increase during recovery. Furthermore, the temperature-associated rise in nocturnal respiratory rate was significantly attenuated.
Results date posted
| 2026 | Year | 10 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 05 | Month | 28 | Day |
Baseline Characteristics
The baseline characteristics of the per-protocol set (n=161) were as follows:
Lactic acid bacteria beverage group (n=82): 38 males, 44 females, mean age 40.8 years, mean BMI 22.9 kg/m2.
Control beverage group (n=79): 38 males, 41 females, mean age 40.7 years, mean BMI 23.0 kg/m2.
Participant flow
Of the 243 consented subjects, 57 were screening failures and 15 discontinued before randomization, leaving 171 subjects randomized (Intent to treat). After excluding 7 subjects who discontinued, 164 subjects were included in the full analysis set (FAS: 82 in the lactic acid bacteria beverage group, 82 in the control beverage group). A further 3 subjects were excluded from the analyses (2 for poor compliance, 1 for missing baseline data), resulting in a per-protocol set (PPS) of 161 subjects (82 in the lactic acid bacteria beverage group, 79 in the control beverage group).
Adverse events
All adverse events were judged by the clinical investigator to be unrelated to the study products.
Outcome measures
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(Subjective fatigue, 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)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065794
