UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049458 |
|---|---|
| Receipt number | R000056309 |
| Scientific Title | Study to confirm the effect of single ingestion of the test food on Na excretion in the urine, A randomized, double-blind, placebo-controlled, crossover study |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/05/10 15:09:17 |
* 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 to confirm the effect of single ingestion of the test food on Na excretion in the urine
Acronym
Study to confirm the effect of single ingestion of the test food on Na excretion in the urine
Scientific Title
Study to confirm the effect of single ingestion of the test food on Na excretion in the urine, A randomized, double-blind, placebo-controlled, crossover study
Scientific Title:Acronym
Study to confirm the effect of single ingestion of the test food on Na excretion in the urine, A randomized, double-blind, placebo-controlled, crossover study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the increasing excretion of dietary Na in the urine by ingesting the test food in healthy subjects after eating an unified diet.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total amount of Na excreted in the urine in 24 hours
Key secondary outcomes
Total urine volume, Na concentration of the urine collected in each time frame, Na amount of the urine collected in each time frame, Body water in each site measured with body composition analyzer
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The test food
Interventions/Control_2
The placebo food
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Japanese men and women aged between 20 and 64 at the time of obtaining consent to participate in the study
(2) Subjects who do not have significant deviations in the screening test
(3) Subjects who can ingest all the salt-containing ingredients in the unified diet [Subjects who do not have ingredients that cannot be taken]
(4) Subjects who can be available on every scheduled days including overnight stays
(5) Subjects who agree to participate in the study and can sign and date the consent form by themselves
Key exclusion criteria
(1) Subjects who have a serious medical history and a history of gastrointestinal resection surgery (excluding appendectomy and endoscopic polypectomy)
(2) Subjects who have a current history of internal disease , including, in particular, failure of kidney function and voiding of urine
(3) Subjects who have allergies to any ingredients in the test food or the unified meals
(4) Heavy alcohol drinkers (>60g of pure alcohol/day) or excessive smokers (>20 cigarettes/day) who cannot quit smoking during the study under the unified management
(5) Subjects who wish to become pregnant during the study, pregnant women (including those who may be pregnant) or breastfeeding
(6) Subjects who are participating in a study to take other test foods or drugs, or a study to apply cosmetics or drugs, or those who plan to participate other study during this study
(7) Subjects who may need to avoid ingesting ingredients whose origin is not clearly indicated in the food and drink used in the study due to religious reasons, etc.
(8) Late night workers, those who frequently work long overtime or work irregular shifts.
(9) Subjects who did not test negative for SARS-Cov-2 in the secondary screening
(10) Subjects who take food containing the test food every day
(11) Subjects who habitually consume health foods, quasi-drugs, and pharmaceuticals that have a hypotensive effect
(12) Subjects whose evaluable data cannot or could not be obtained due to menstruation on a test day
(13)Subjects who are judged to be inappropriate for this study by the principal investigator with other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Ueno |
Organization
Social Medical Care Corporation Taiseikai Fukuoka Kinen PET Kenshin Center
Division name
Internal Medicine
Zip code
810-0054
Address
2-16-16, Imagawa, Chuo-ku, Fukuoka-shi, Fukuoka, 810-0054, Japan
TEL
011-223-3130
takehara@csc-smo.co.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Takehara |
Organization
Clinical Support Corporation, Limited
Division name
Food Service Division
Zip code
060-0061
Address
4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido, 060-0061, Japan
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
Social Medical Care Corporation Taiseikai Fukuoka Kinen PET Kenshin Center
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical 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
Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee
Address
61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan
Tel
011-882-0111
matsuda@ughp-cpc.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
| 2023 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 25 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056309
