UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054110 |
|---|---|
| Receipt number | R000061774 |
| Scientific Title | Effects of season, physical activity, and water consumption on water turnover: N-of-1 crossover intervention trial |
| Date of disclosure of the study information | 2024/04/10 |
| Last modified on | 2024/04/10 19:08:50 |
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Basic information
Public title
Effects of season, physical activity, and water consumption on water turnover: N-of-1 crossover intervention trial
Acronym
Season, physical activity, water consumption, and water turnover
Scientific Title
Effects of season, physical activity, and water consumption on water turnover: N-of-1 crossover intervention trial
Scientific Title:Acronym
Season, physical activity, water consumption, and water turnover
Region
| Japan |
Condition
Condition
n/a
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of seasonal changes, physical activity, and water consumption on water turnover.
Basic objectives2
Others
Basic objectives -Others
To determine the effects of season, physical activity, and water consumption on intra-individual variability in water turnover by having one participant repeatedly change water consumption and physical activity for approximately one year.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
water turnover
Key secondary outcomes
24 h urine volume, urinary biomarkers, blood biomarkers, defecation status, dietary intake, PWV
Base
Study type
Interventional
Study design
Basic design
n-of-1
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
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
The intervention period lasts 56 weeks, with 4 intervention trials conducted across 7 cycles.
Each cycle includes 4 intervention trials of 10 days each, with a 3-day washout period between trials.
Control (10 days x 7/year),increased water consumption (+1500 ml/day, 10 days x 7/year), increased physical activity (walking +9.4 km/day, 10 days x 7/year), increased water + increased physical activity (water consumption +1500 ml/day, walking +9.4 km/day, 10 days x 7/year)
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
Adult women who independently lives and do not have serious illnesses
Key exclusion criteria
Patients with serious illnesses such as cancer, myocardial infarction, stroke, etc.
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Miyachi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
04-2947-7313
miyachim@waseda.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Inoue |
Organization
Waseda University
Division name
Graduate School of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, Japan
TEL
04-2947-6936
Homepage URL
yumiko.inoue@asagi.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency Charitable Trust
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
1-104 Totsuka-cho, Shinjuku, Tokyo, 169-8050, Japan
Tel
03-5272-1639
rinri@list.waseda.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
| 2024 | Year | 04 | Month | 10 | 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
| 2024 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061774
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
