UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056638 |
|---|---|
| Receipt number | R000064709 |
| Scientific Title | Effects of meal timing on interstitial glucose concentrations during the menstrual cycle |
| Date of disclosure of the study information | 2025/01/08 |
| Last modified on | 2025/01/06 15:17:16 |
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Basic information
Public title
Effects of meal timing on interstitial glucose concentrations during the menstrual cycle
Acronym
Effects of meal timing on interstitial glucose concentrations during the menstrual cycle
Scientific Title
Effects of meal timing on interstitial glucose concentrations during the menstrual cycle
Scientific Title:Acronym
Effects of meal timing on interstitial glucose concentrations during the menstrual cycle
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to examine the effects of meal timing on interstitial glucose concentrations during the menstrual cycle
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interstitial fluid glucose levels
Key secondary outcomes
core body temperature, estradiol, progesterone
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the meal at breakfast, lunch, and dinner during the follicular phase.
Interventions/Control_2
Intake the meal at breakfast, lunch, and dinner during the luteal phase.
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Individuals who aged 18-45.
Individuals who do not have menstrual irregularities and do not plan to become pregnant during the study period.
Obtained written informed consent from the participant before participation.
Key exclusion criteria
Individuals who have irregular menstrual patterns, Individuals who are or are possibly pregnant, Individuals who have food allergies,Individuals who are diagnosed with diabetes or dyslipidaemia, taking any antioxidant, anti-obesity, or antidiabetes medication and supplements, Individuals who are using depression, sleeping, steroid medications, Individuals who suffered from sleep apnea, Individuals who are smoker, Individuals who are habitual drinkers, Individuals who are set pacemaker and metal in body (excluding dental filling), Individuals who are engaged shift work and travel with jetlag within 2 weeks, Individuals who routinely perform strenuous aerobic exercise.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takahashi |
Organization
Institute of Science Tokyo
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama Meguro-ku, Tokyo, 152-8550
TEL
03-5734-2904
takahashi.m.bp@m.titech.ac.jp
Public contact
Name of contact person
| 1st name | Saeka |
| Middle name | |
| Last name | Fuke |
Organization
Institute of Science Tokyo
Division name
School of Environment and Society
Zip code
152-8550
Address
2-12-1, Ookayama Meguro-ku, Tokyo, 152-8550
TEL
03-5734-2904
Homepage URL
fuke.s.aa@m.titech.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Takahashi Masaki
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
2-12-1, Ookayama Meguro-ku, Tokyo
Tel
03-5734-3808
hitorinri@jim.titech.ac.jp
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 | 01 | Month | 08 | 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
| 2024 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 01 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064709
