UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061996 |
|---|---|
| Receipt number | R000070595 |
| Scientific Title | Evaluation of Exhaled Breath Analysis and Physiological Parameters in Females |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/22 08:50:10 |
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Basic information
Public title
Evaluation of Exhaled Breath Analysis and Physiological Parameters in Females
Acronym
Evaluation of Exhaled Breath Analysis and Physiological Parameters in Females
Scientific Title
Evaluation of Exhaled Breath Analysis and Physiological Parameters in Females
Scientific Title:Acronym
Evaluation of Exhaled Breath Analysis and Physiological Parameters in Females
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An exploratory study to evaluate energy metabolism (specifically fat oxidation) and various physiological biomarkers in female subjects
Basic objectives2
Others
Basic objectives -Others
Exploratory investigation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
energy expenditure
Key secondary outcomes
body temperature, heart rate, autonomic nervous system activity indices (HRV), sweat rate, sleep parameters, salivary hormones, and various questionnaires.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Ergometer exercise
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Japanese female subjects aged 18 years or older at the time of providing informed consent.
Subjects with a normal menstrual cycle (between 25 and 38 days).
Subjects with a menstrual duration of 3 to 7 days.
Subjects with a Body Mass Index (BMI) of 18.5 kg/m2 or more and less than 25.0 kg/m2.
Subjects who have received a full explanation of the study's purpose and procedures, have demonstrated good understanding, and have voluntarily provided written informed consent to participate in the study.
Key exclusion criteria
Subjects currently receiving medication or outpatient treatment for any serious disease.
Subjects with a history or current diagnosis of mental illness, diabetes, hepatic disease, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disorder, or other serious conditions.
Subjects with severe menstrual pain that cannot be controlled even with analgesics.
Subjects unable to perform physical exercise tests.
Subjects unable to consume the prescribed study meals.
Subjects who routinely (e.g., 3 times or more per week) consume over-the-counter (OTC) drugs, quasi-drugs, health foods, supplements, Foods for Specified Health Uses (FOSHU), or Foods with Function Claims, and are unable to discontinue their use after providing consent.
Subjects who are currently pregnant or breastfeeding, or who intend to become pregnant during the study period.
Subjects with an average daily alcohol consumption exceeding 60g of pure alcohol.
Current smokers, or those with a smoking habit within one year prior to the start of the study.
Subjects planning significant changes to their lifestyle (diet, sleep, exercise habits, etc.) during the study period, such as long-term travel.
Subjects with extremely irregular dietary habits, or those with irregular life rhythms, such as shift workers or late-night workers.
Subjects who have experienced a body weight fluctuation of 5% or more within the 3 months prior to the study.
Subjects currently participating in another clinical trial, those within 4 weeks of completing another trial, or those planning to participate in another trial after consenting to this study.
Other individuals judged as unsuitable for the study by the principal investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Motoya |
| Middle name | |
| Last name | Ikeguchi |
Organization
Okayama Prefectural University
Division name
Faculty of Health and Welfare Science, Department of Nutritional Science
Zip code
719-1197
Address
111, Kuboki, Soja-shi, Okayama
TEL
0866942154
motoya_ikeguchi@fhw.oka-pu.ac.jp
Public contact
Name of contact person
| 1st name | Yukino |
| Middle name | |
| Last name | Koshinaka |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department R&D Headquarters
Zip code
562-0029
Address
4-1-66 Saito Aokita, Minoh, Osaka
TEL
07055828538
Homepage URL
y.koshinaka@kobayashi.co.jp
Sponsor or person
Institute
KOBAYASHI Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okayama Prefectural University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Prefectural University Ethics Committee
Address
111, Kuboki, Soja-shi, Okayama
Tel
0866924154
motoya_ikeguchi@fhw.oka-pu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
26-10
Org. issuing International ID_1
Okayama Prefectural University Ethics Committee
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 | 06 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070595
