UMIN-CTR Clinical Trial

Public title

Study on the Association of Vascular function and Eating habits with Sarcopenia

Acronym

SAVES Survey

Scientific Title

Study on Association between vascular function, dietary habits, and sarcopenia in middle-aged and older adults and patients with kidney disease

Scientific Title:Acronym

SAVES Survey

Region

Japan

Condition

Chronic Kidney Disease and Healthy Adults

Classification by specialty

Nephrology	Geriatrics	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To cross-sectionally investigate the association of vascular function and dietary habits with sarcopenia in patients with chronic kidney disease and health check-up examinees.

Basic objectives2

Others

Basic objectives -Others

Examination of the association of vascular function and dietary habits with sarcopenia

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Prevalence of sarcopenia, skeletal muscle mass, grip strength, vascular function indices, and nutrient intake based on a food frequency questionnaire(Timepoint: at study enrollment)

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

40

years-old

<

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients who visit Iyasaka Kidney Clinic as outpatients or for health check-ups between the date of approval by the head of the research institution and the end of March 2029.
2.Aged 40 years or older at the time of obtaining informed consent (No upper age limit is set. This is to evaluate age-related muscle mass loss and muscle weakness, which are the pathology of sarcopenia.)
3.Regardless of gender.
4.Patients who are receiving stable treatment.
5.Patients who can provide written informed consent for study participation of their own free will.

Key exclusion criteria

1.Female patients who are pregnant, breastfeeding, or possibly pregnant.
2.Patients with severe cardiac, hepatic, or biliary tract diseases (left ventricular ejection fraction of 40% or less, AST of 150 IU or higher, or ALT of 150 IU or higher).
3.Patients with concurrent malignant tumors or inflammatory diseases.
4.Other patients deemed unsuitable for the study by the attending physician.

Target sample size

100

Name of lead principal investigator

1st name	Miyuki
Middle name
Last name	Hisanari

Organization

Okayama University

Division name

Faculty of Education

Zip code

700-8530

Address

3-1-1 Tsuhima-naka, Okayama City, Okayama

TEL

086-251-7677

Email

hisanari@okayama-u.ac.jp

Name of contact person

1st name	Miyuki
Middle name
Last name	Hisanari

Organization

Okayama University

Division name

Faculty of Education

Zip code

700-8530

Address

3-1-1 Tsushima-naka, Okayama City, Okayama

TEL

086-251-7677

Homepage URL

Email

hisanari@okayama-u.ac.jp

Institute

Okayama University

Institute

Department

Personal name

Miyuki Hisanari

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Kurume University

Name of secondary funder(s)

Organization

Okayama University Tsushima Area Research Ethics Committee

Address

1-1-1 Tsushima-naka, Okayama City, Okayama

Tel

086-251-8460

Email

tsushima-rinri@okayama-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

いやさか腎クリニック（広島県）

Date of disclosure of the study information

2026

Year

04

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

11

Month

13

Day

Date of IRB

2026

Year

01

Month

13

Day

Anticipated trial start date

2026

Year

04

Month

20

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a cross-sectional observational study targeting patients with chronic kidney disease and health check-up examinees.
The data to be collected from participants include:
1.Clinical data: Obtained from electronic medical records (blood and urine tests, medical history, etc.)
2.Physical measurements: Muscle mass (e.g., BIA method), grip strength, and physical function (e.g., gait speed)
3.Vascular function evaluation: Non-invasive blood pressure and pulse wave measurements
4.Questionnaires: Food frequency questionnaire and nutritional status assessment

The objective is to multidimensionally verify the association of vascular function and dietary habits with the pathology of sarcopenia.

Registered date

2026

Year

04

Month

17

Day

Last modified on

2026

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070129