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 2024/05/28 20:04:27

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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

Email

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


Email

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

Email

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

No longer recruiting

Date of protocol fixation

2024 Year 03 Month 19 Day

Date of IRB

2024 Year 04 Month 17 Day

Anticipated trial start date

2024 Year 05 Month 27 Day

Last follow-up date

2025 Year 06 Month 23 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 05 Month 28 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
Registered date File name

Research case data
Registered date File name