UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046977 |
|---|---|
| Receipt number | R000053597 |
| Scientific Title | Study on the relationship between continuous eating of high-potassium diet and urinary sodium-to-potassium ratio and its acceptability as a diet |
| Date of disclosure of the study information | 2022/02/23 |
| Last modified on | 2023/04/14 15:16:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on the relationship between continuous eating of high-potassium diet and urinary sodium-to-potassium ratio and its acceptability as a diet
Acronym
Study on the relationship between continuous eating of high-potassium diet and urinary sodium-to-potassium ratio and its acceptability as a diet
Scientific Title
Study on the relationship between continuous eating of high-potassium diet and urinary sodium-to-potassium ratio and its acceptability as a diet
Scientific Title:Acronym
Study on the relationship between continuous eating of high-potassium diet and urinary sodium-to-potassium ratio and its acceptability as a diet
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understanding the effect of high-potassium diet on the urinary sodium-to-potassium ratio
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary sodium-to-potassium ratio
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects eat the control diet (salt and potassium intake based on the average of Japanese people) for 2 weeks.
Interventions/Control_2
Subjects eat the low-salt diet (reduced salt intake from the control diet) for 2 weeks.
Interventions/Control_3
Subjects eat the high-potassium diet (increased potassium intake from the control diet) for 2 weeks.
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
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
1) Students at Kagawa Nutrition University
2) Healthy women, the ages of more than 18 years old and less than 30 years old
3) Subjects who get the sufficient explanation of the purpose and content of this study, have the ability to consent, voluntarily apply with the sufficient understanding, and approve of the participation in the document
Key exclusion criteria
1) Subjects with severe hepatic, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine and metabolic diseases / disorders
2) Subjects who suffer from diseases/ disorders with continuous medical treatment or with medical history of severe diseases/ disorders needed medical treatment
3) Subjects who suffer from diseases/ disorders that affects the study and are receiving medical treatment from medical institution or have surgical history of digestive system (except appendectomy)
4) Subjects with allergies to the ingredients
5) Subjects who have received dietary guidance on potassium from a doctor or nutritionist
6) Subjects who had participated in other clinical trials including drug and food within 1 month
7) Subjects who are judged as inappropriate by investigators
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi, Japan
TEL
0287-36-2935
Yusuke_Ushida@kagome.co.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Ishida |
Organization
Kagawa Nutrition University
Division name
Laboratory of Administrative Dietetics
Zip code
350-0288
Address
3-9-21 Chiyoda, Sakado-shi, Saitama, Japan
TEL
049-281-3211
Homepage URL
ishida@eiyo.ac.jp
Sponsor or person
Institute
KAGOME CO., LTD
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KAGOME CO., LTD Institution Review Board
Address
3-21-1, Hamacho, Nihonbashi, Chuo-ku, Tokyo
Tel
03-5623-8501
takuji_hayakawa@kagome.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-R01
Org. issuing International ID_1
Kagome 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
| 2022 | Year | 02 | Month | 23 | 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
43
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
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 22 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053597
