UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042956 |
|---|---|
| Receipt number | R000049039 |
| Scientific Title | Alteration of individual dietary salt intake with age in the Japanese population; follow-up study |
| Date of disclosure of the study information | 2021/01/09 |
| Last modified on | 2021/01/11 09:06:52 |
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Basic information
Public title
Alteration of dietary salt intake with age
Acronym
ASIA
Scientific Title
Alteration of individual dietary salt intake with age in the Japanese population; follow-up study
Scientific Title:Acronym
ASIA
Region
| Japan |
Condition
Condition
general population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that individual salt intake increases with age in the Japanese adults.
Basic objectives2
Others
Basic objectives -Others
The National Health and Nutrition Survey Japan demonstrated high salt intake and higher salt intake in old compared to young populations. Although this observation implies that individual salt intake increases with age, tracking alterations in salt intake with age is necessary to discover the truth. If salt intake increases with age, this should be quite important information for devising population-based strategies to lower salt intake. Thus, the present study was designed to test the hypothesis that individual salt intake increases with age in the Japanese adults using retrospective follow-up design.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in individual dietary salat intake for 10 years
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women who participated in a baseline health checkup (2008-2009) at our center and had a health checkup 10 years later.
Key exclusion criteria
Renal insufficiency (creatinine 1.5 mg/dL or more), malignant neoplasm, active inflammatory disease, and a history of cardiovascular events.
Target sample size
2600
Research contact person
Name of lead principal investigator
| 1st name | YASUAKI |
| Middle name | |
| Last name | DOHI |
Organization
Nagoya Gakuin University
Division name
Faculty of Rehabilitation Sciences
Zip code
456-0062
Address
3-1-17 Taiho, Atsuta, Nagoya 480-1298, Japan
TEL
0526784078
ydohi@ngu.ac.jp
Public contact
Name of contact person
| 1st name | YASUAKI |
| Middle name | |
| Last name | DOHI |
Organization
Nagoya Gakuin University
Division name
Faculty of Rehabilitation Sciences
Zip code
456-0062
Address
3-1-17 Taiho, Atsuta, Nagoya 480-1298, Japan
TEL
0526784078
Homepage URL
ydohi@ngu.ac.jp
Sponsor or person
Institute
Nagoya Gakuin University
Institute
Department
Personal name
Funding Source
Organization
none
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
JA Shizuokakohseiren Enshu Hospital Ethics Committee
Address
1-1-1 Chuo, Naka-ku, Hamamatsu, Shizuoka, 430-0929, Japan
Tel
053-453-1111
esoumu@kou.ja-shizuoka.or.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
| 2021 | Year | 01 | Month | 09 | 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
2598
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
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) 10-year follow-up study
We compared individual-level changes in salt intake at the beginning and end of this period. Among this group, 1543 participated in our annual health checkup each year during the 10-year period, and in these participants, we assessed year over year longitudinal changes in salt intake.
(2) Cross-sectional study
To investigate changes in salt intake in the region during that time, participants in our health checkup program between July 2008 and June 2009 and those between July 2018 and June 2019 (10-year time point) were compared. To minimize the effects of potential confounding factors, a propensity-matched analysis was applied.
(3) Procedures
The checkup program included an interview regarding health status, routine physical examination, chest X-ray, electrocardiography, and laboratory assessment of cardiovascular risk factors. Salt intake was assessed by estimating 24-hour urinary sodium excretion using a spot urine sample.
(4) Statistical analysis
In the follow-up study, changes in salt intake during the 10-year period were assessed using paired Student t-tests, while repeated-measures analysis of variance was used to assess changes in salt intake with age in the 1543 participants with complete annual data during the 10-year period (from 2008 to 2018).The mean daily salt intake per person in the region where the present study was conducted at the initial and 10-year time points was compared using propensity-matched models with unpaired Student t-tests.
Management information
Registered date
| 2021 | Year | 01 | Month | 09 | Day |
Last modified on
| 2021 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049039
