UMIN-CTR Clinical Trial

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

general population

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Changes in individual dietary salat intake for 10 years

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nagoya Gakuin University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

01

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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