UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063430 |
|---|---|
| Receipt number | R000072601 |
| Scientific Title | Effects of breakfast on acid-base balance in body fluids |
| Date of disclosure of the study information | 2026/10/27 |
| Last modified on | 2026/10/27 16:48:22 |
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Basic information
Public title
Effects of breakfast on acid-base balance in body fluids
Acronym
Effects of breakfast on acid-base balance in body fluids
Scientific Title
Effects of breakfast on acid-base balance in body fluids
Scientific Title:Acronym
Effects of breakfast on acid-base balance in body fluids
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of breakfast consumption and its nutritional composition on body fluid acid-base balance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary pH
Key secondary outcomes
Urinary calcium, phosphorus, magnesium, potassium, sodium and uric acid excretion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Skipping breakfast.
Interventions/Control_2
Provision of a standard meal for breakfast.
Interventions/Control_3
Provision of a high-acidity meal for breakfast.
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 | months-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Women between the ages of 20 and 29.
2. A participant who consented to the study.
Key exclusion criteria
1. Persons with a history or current medical history of glucose tolerance, renal, hepatic disfunction.
2. Those who may have allergic symptoms to the test meals.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masae |
| Middle name | |
| Last name | Sakuma |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences
Zip code
813-8529
Address
1-1-1, Kasumigaoka, Higashi-ku, Fukuoka
TEL
092-692-3180
m-sakuma@fwu.ac.jp
Public contact
Name of contact person
| 1st name | Masae |
| Middle name | |
| Last name | Sakuma |
Organization
Fukuoka Women's University
Division name
International College of Arts and Sciences
Zip code
813-8529
Address
1-1-1, Kasumigaoka, Higashi-ku, Fukuoka
TEL
092-692-3180
Homepage URL
m-sakuma@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Women's University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Fukuoka Women's University
Address
1-1-1, Kasumigaoka, Higashi-ku, Fukuoka
Tel
092-661-2411
fwusoumu@fwu.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
| 2026 | Year | 10 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 10 | Month | 27 | Day |
Last modified on
| 2026 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072601
