UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049540 |
|---|---|
| Receipt number | R000056410 |
| Scientific Title | Research on the effects of salt excretion by continuous intake of salt excretion supplements and behavioral change by recognizing various nutrients and salt intake in one's dietary habits |
| Date of disclosure of the study information | 2022/11/17 |
| Last modified on | 2023/05/19 09:46:00 |
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Basic information
Public title
Research on the effects of salt excretion by continuous intake of salt excretion supplements and behavioral change by recognizing various nutrients and salt intake in one's dietary habits
Acronym
Research on the effects of salt excretion by continuous intake of salt excretion supplements and behavioral change by recognizing various nutrients and salt intake in one's dietary habits
Scientific Title
Research on the effects of salt excretion by continuous intake of salt excretion supplements and behavioral change by recognizing various nutrients and salt intake in one's dietary habits
Scientific Title:Acronym
Research on the effects of salt excretion by continuous intake of salt excretion supplements and behavioral change by recognizing various nutrients and salt intake in one's dietary habits
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of taking salt excretion supplements for 7 days in Japanese people aged 18 and over, and the effect of recognizing their own intake of various nutrients and salt on their eating habits and health awareness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary sodium level (creatinine corrected)
Key secondary outcomes
Urinary potassium level (creatinine correction)
blood pressure
body weight
diet survey
Questionnaire on health awareness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
For 14 days, use the dietary guidance DX tool "Calomeal" to know and visualize various nutrients and salt intake in each person's diet. In addition, ingest salt excretion supplements every day for a total of 7 days from the 8th day to the 14th day of the test, 3 tablets for each meal, a total of 9 tablets per day. During the test period, salt intake is evaluated using a mail-in test kit "Siocheck Plus".
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Japanese who are 18 years of age or older at the time of informed consent
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food
3.Persons who regularly take large amounts of the test food
4.Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect the absorption or discharge of salt
5.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
6.Persons who were judged as inappropriate for study participants by the principal investigator
7.Persons who are lactating, pregnant, or planning or hoping to become pregnant during the study period
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Hayashi |
Organization
TOY MEDICAL Co., Ltd.
Division name
Product Headquarters
Zip code
861-3131
Address
750-1 Toyoaki, Mifune Town, Kamimashiki District, Kumamoto Prefecture, JAPAN
TEL
096-281-0007
hayashi@toymedical.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Hayashi |
Organization
TOY MEDICAL Co., Ltd.
Division name
Product Headquarters
Zip code
861-3131
Address
750-1 Toyoaki, Mifune Town, Kamimashiki District, Kumamoto Prefecture, JAPAN
TEL
096-281-0007
Homepage URL
hayashi@toymedical.jp
Sponsor or person
Institute
TOY MEDICAL Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
TOY MEDICAL Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2022 | Year | 11 | Month | 17 | 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
166
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 | 11 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | 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 | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056410
