UMIN-CTR Clinical Trial

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
Email	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
Email	ydohi@ngu.ac.jp

Sponsor
Institute	Nagoya Gakuin University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049039

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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