臨床研究等提出・公開システム

Diet improvement program to reduce salt intake and increase potassium intake

Diet improvement program

Miura Katsuyuki

Non-Profit Organization The Japanese Society of Hypertension

3-28-8 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN

miura@belle.shiga-med.ac.jp

Yano Yuichiro

Yokohama City University

1-1-1 Fukuura, Kanazawa-ku, Yokohama, Kanagawa

+81-45-370-7949

yyano@jichi.jp

Recruiting

July. 20, 2021

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

prevention purpose

Employees in the Japan Airlines Co., Ltd. or Daiwa Securities Co. Ltd. who also took a health check at 2020.
Persons who give informed consent from the date of IRB approval to March 31, 2022.
Persons 20 to 59 years of age when they give informed consent.
Persons who can have own iPhone and use it.

People who experience a loss of appetite.
A pregnant woman.
Persons with chronic kidney disease or diabetic kidney disease.

Both

People with high estimated usual sodium intake or low estimated potassium intake.

The Screening Process
We will enroll approximately 500 persons who meet the inclusion criteria. Then, they will have a spot urine test to assess whether a person qualifies for the intervention. Of the 500 participants, we will enroll 320 participants with >=4.0 casual (spot)sodium-to-potassium ratio or >=10g/day estimated 24-h urinary sodium.

Intervention Phase
320 participants will be randomly assigned into four groups (n=80 in Group A, n=80 in Group B, n=80 in Group C, and n=80 in Group D). Randomization will be performed using a dynamic randomization algorithm designed to minimize imbalance in age, sex, and the proportion of persons who will take a specific health guidance.

Group A
Participants will be required to reduce salt and increase potassium intake in diets based on the textbook on diet. They will also be required to take the following actions.

1. Spot urine checks 1, 2, and 3 months later after the intervention begins.
2. Self-monitoring (i.e., recording dietary intake and evaluation of records).
3. Online nutrition counseling regarding to salt and potassium intake 1, 2, and 3 months later after the intervention begins, using an app developed by MEDCARE, Inc.

Group B
Participants will be required to reduce salt and increase potassium intake in diets based on the textbook on diet. They will also be required to take the following actions.

1. Spot urine checks 1, 2, and 3 months later after the intervention begins.
2. Self-monitoring (i.e., recording dietary intake and evaluation of records).
3. An e-mail will be sent to a participant to check whether they perform self-monitoring 1, 2, and 3 months later after the intervention begins.

Group C
Participants will be required to reduce salt and increase potassium intake in diets based on the 2 pages documentation on diet. They will receive spot urine check 3 months later after the intervention begins.

Group D (control)
No action is required except for receiving spot urine check 3 months later after the intervention begins.

Salt and potassium intake

Reduce salt intake and increase potassium intake

D004039

D004039

Casual (spot)sodium-to-potassium ratio.

Estimated 24-h urinary sodium excretion.
Estimated 24-h urinary potassium excretion.

+81-3-6801-9786

June. 28, 2021

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