UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058604 |
|---|---|
| Receipt number | R000067009 |
| Scientific Title | Placebo-controlled randomized double-blind crossover trial on the effect of continuous intake of lactic acid bacteria on improving weather-related illness symptoms |
| Date of disclosure of the study information | 2026/07/24 |
| Last modified on | 2025/07/25 22:17:31 |
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Basic information
Public title
Placebo-controlled randomized double-blind crossover trial on the effect of continuous intake of lactic acid bacteria on improving weather-related illness symptoms
Acronym
Placebo-controlled randomized double-blind crossover trial on the effect of continuous intake of lactic acid bacteria on improving weather-related illness symptoms
Scientific Title
Placebo-controlled randomized double-blind crossover trial on the effect of continuous intake of lactic acid bacteria on improving weather-related illness symptoms
Scientific Title:Acronym
Placebo-controlled randomized double-blind crossover trial on the effect of continuous intake of lactic acid bacteria on improving weather-related illness symptoms
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A placebo-controlled, randomized, double-blind crossover trial will be conducted on women with weather-related illness to examine the effects of continuous consumption of the test food for four weeks on improving weather-related illness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Frequency of symptoms caused by weather conditions
Key secondary outcomes
(1) POMS-2 Adult Short Form
(2) Japanese Version of the Weather-Related Illness and Weather Sensitivity Questionnaire (Japanese Version of METEO-Q)
(3) VAS (neck and shoulder stiffness, headache, dizziness, fatigue, mental distress)
(4) Salivary cortisol, salivary amylase *Objective indicators only
(5) Autonomic nervous system stress indicators (LF/HF, total power) *Objective indicators only
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume the test food for four weeks, then consume the placebo food for four weeks after a washout period.
Interventions/Control_2
Consumption of placebo food for four weeks, followed by consumption of test food for four weeks after washout period.
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Healthy adult women aged 20 to 49 at the time of obtaining consent to participate in the trial
(2) Individuals who are aware of changes in their physical condition due to weather conditions
(3) Individuals who have received sufficient explanation of the purpose and content of this trial, have the capacity to consent, have fully understood the trial, have volunteered of their own free will, and have given their consent through electronic informed consent
Key exclusion criteria
(1) Under treatment or planning treatment for gynecological conditions (e.g., dysmenorrhea, PMS, PMDD, menopausal symptoms, uterine/ovarian/breast disorders).
(2) Under treatment or planning treatment for mental (e.g., depression, anxiety, insomnia), thyroid (e.g., Graves's, Hashimoto's), autonomic, migraine, or ENT disorders (e.g., vertigo, tinnitus, hearing loss).
(3) Having chronic diseases requiring regular treatment.
(4) History of major gastrointestinal surgery (e.g., gastrectomy, bowel resection), or under treatment for serious gastrointestinal conditions (excluding appendectomy only).
(5) Pregnant, breastfeeding, possibly pregnant, or planning pregnancy during the study.
(6) Allergy to study product.
(7) Regular use of health/functional foods or supplements that cannot be discontinued.
(8) Heavy smokers (>=21 cigarettes/day).
(9) High alcohol consumers (>=60 g/day, >=6 days/week; e.g., 3 servings of sake, 1500 mL beer, 2 shochu, or 5 glasses of wine).
(10) Irregular lifestyle (e.g., night/shift workers).
(11) Anticipated major lifestyle changes (e.g., relocation, long trip) or changes in diet/exercise.
(12) Participation in other trials within 4 weeks or during the study period.
(13) Judged ineligible by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Trial Department , Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Clinical Trial Department , Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
Homepage URL
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Food 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
Institutional review board of Tsukiji Futaba Clinic
Address
1-9-9, Tsukiji, Chuou-ku, Tokyo, Japan
Tel
03-6226-5812
tohru@hikobae.net
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
| 2026 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 28 | 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 | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067009
