UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056156 |
|---|---|
| Receipt number | R000064161 |
| Scientific Title | Research on nutritional monitoring using simple, quick and non-invasive self-testing kits and changes in dietary habits and nutritional status through the use of salt care foods |
| Date of disclosure of the study information | 2024/11/15 |
| Last modified on | 2024/11/14 14:05:12 |
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Basic information
Public title
Research on nutritional monitoring using simple, quick and non-invasive self-testing kits and changes in dietary habits and nutritional status through the use of salt care foods
Acronym
Research on nutritional monitoring using simple, quick and non-invasive self-testing kits and changes in dietary habits and nutritional status through the use of salt care foods
Scientific Title
Research on nutritional monitoring using simple, quick and non-invasive self-testing kits and changes in dietary habits and nutritional status through the use of salt care foods
Scientific Title:Acronym
Research on nutritional monitoring using simple, quick and non-invasive self-testing kits and changes in dietary habits and nutritional status through the use of salt care foods
Region
| Japan |
Condition
Condition
Healthy women aged 30 years and over
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate nutritional status using a self-testing kit and to examine the effect of suppressing salt absorption when Japanese women over 30 years of age consume salt care foods for one week. Furthermore, the aim is to evaluate the impact of understanding various nutrients and salt intake on dietary habits and health awareness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salt, calcium, magnesium, vitamin C, zinc, iron (estimated from questionnaire), water, carbohydrates, fat burning, oxidative stress, vegetable intake, alcohol intake
Key secondary outcomes
Questionnaire on health awareness, questionnaire on behavior change
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take 3 tablets of salt absorption inhibitor supplement (250mg/tablet, Toy Medical Co., Ltd.) every day for one week before each meal.
Interventions/Control_2
Use 1 packet of Zero Series Seasoning Shio (1000mg/bag, Toy Medical Co., Ltd.) with each meal during the test period.
Interventions/Control_3
Live a normal life (non-intervention)
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women aged 30 and over who live in Kumamoto Prefecture.
Those who have received a sufficient explanation of the purpose and content of this research, have the capacity to consent, understand it well, wish to participate in the research voluntarily, and can consent to this research in writing.
Key exclusion criteria
1) Those who have a chronic disease and are receiving drug treatment, or those who have a history of serious illness.
2) Those who have allergies to the test food
3) Those who regularly consume large amounts of test foods (other than the test foods "Del Sol" and "Reishio"), it is possible to consume food products containing seaweed in daily life at the same frequency as before. do.)
4) Those who regularly use medicines, foods with health claims (foods for specified health uses, foods with functional claims, and foods with nutritional function claims) that may affect the absorption and excretion of salt.
5) Those who have participated in other studies within one month before the start of the study, or those who plan to participate in other studies after consenting to this study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Takeshita |
Organization
TOY MEDICAL Co., Ltd.
Division name
CEO
Zip code
861-4163
Address
48-1, Tomiaimachi-shijimizu, Minami-ku kumamoto-shi, Kumamoto Prefecture
TEL
096-342-6477
info@toymedical.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Hayashi |
Organization
TOY MEDICAL Co., Ltd.
Division name
Research and Development Headquarters
Zip code
861-4163
Address
48-1, Tomiaimachi-shijimizu, Minami-ku kumamoto-shi, Kumamoto Prefecture
TEL
096-342-6477
Homepage URL
info@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
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee
Address
Meieki Diamatetsu Building 11F, 1-1-17 Meieki, Nishi-ku, Nagoya, Aichi Prefecture
Tel
080-5055-3551
hagiwara.keitaro@yuurea.co.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 | 11 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064161
