UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060811 |
|---|---|
| Receipt number | R000069302 |
| Scientific Title | A 3-Month Prospective Study of Combined Exercise and Nutritional Counseling in Hospital Staff: Effects on Liver Function, Body Composition, and Lifestyle |
| Date of disclosure of the study information | 2026/03/05 |
| Last modified on | 2026/03/03 18:19:10 |
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Basic information
Public title
A 3-Month Prospective Study of Combined Exercise and Nutritional Counseling in Hospital Staff: Effects on Liver Function, Body Composition, and Lifestyle
Acronym
A 3-Month Prospective Study of Combined Exercise and Nutritional Counseling in Hospital Staff: Effects on Liver Function, Body Composition, and Lifestyle
Scientific Title
A 3-Month Prospective Study of Combined Exercise and Nutritional Counseling in Hospital Staff: Effects on Liver Function, Body Composition, and Lifestyle
Scientific Title:Acronym
A 3-Month Prospective Study of Combined Exercise and Nutritional Counseling in Hospital Staff: Effects on Liver Function, Body Composition, and Lifestyle
Region
| Japan |
Condition
Condition
A 3-Month Prospective Study of Combined Exercise and Nutritional Counseling in Hospital Staff: Effects on Liver Function, Body Composition, and Lifestyle
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fatty liver disease, lifestyle-related diseases, and chronic kidney disease are rapidly increasing. Hepatic steatosis can lead to liver fibrosis and is frequently accompanied by obesity, impaired glucose metabolism, hypertension, and other comorbidities. Increasing physical activity through aerobic exercise and resistance training, together with optimizing caloric and salt intake, is presumed to improve liver function and metabolic parameters.1) In this study, we combined exercise counseling, a dietary intervention provided by registered dietitians, and body composition assessment using InBody, and evaluated the usefulness of a 3-month intervention by examining its effects on liver function, metabolic parameters, body composition, and lifestyle behaviors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary endpoint primary outcome
Change in ALT Delta ALT
Secondary endpoints secondary outcomes
Changes in laboratory parameters liver function lipids glycemic indices renal function urinalysis
AST gGTP HbA1c HDL C LDL C TG eGFR blood glucose urinalysis
Changes in body composition and anthropometric measures
InBody BIA body weight BMI skeletal muscle mass fat mass body fat percentage visceral fat level
Changes in physical activity and dietary habits
Estimated basal metabolic rate BMR
IPAQ Short Form IPAQ Long Form International Physical Activity Questionnaire
GPAQ Global Physical Activity Questionnaire
Exercise habits questionnaire
BDHQ Brief type Self administered Diet History Questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Exercise guidance using a YouTube playlist
Dietary intervention by a registered dietitian
Body composition assessment using InBody
These components are combined to evaluate the effects of a 3-month intervention on liver function, metabolic parameters, body composition, and lifestyle behaviors.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligible participants are in-hospital staff members of Shigei Hospital who wish to attend the staff-oriented fatty liver clinic and who meet at least one of the following criteria. Participants must receive a full explanation of the study and provide written informed consent based on sufficient understanding and voluntary agreement.
Body mass index (BMI) >= 23 kg/m2 and waist circumference >= 94 cm in men or >= 80 cm in women.
Fasting plasma glucose >= 100 mg/dL, HbA1c >= 5.7%, diagnosis of type 2 diabetes mellitus, or current use of antidiabetic medication.
Blood pressure >= 135/85 mmHg or current use of antihypertensive medication.
Triglycerides >= 150 mg/dL or current use of lipid-lowering medication.
Low HDL cholesterol: <= 40 mg/dL in men or <= 50 mg/dL in women.
Key exclusion criteria
Age < 20 years or >= 65 years.
Presence of liver cirrhosis, cardiovascular disease, malignant neoplasm, pregnancy, or severe limitations in physical activity.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | MIWA |
| Middle name | |
| Last name | KAWANAKA |
Organization
Okayama University
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Okayama City, Okayama
TEL
086-235-7219
m.kawanaka@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | MIWA |
| Middle name | |
| Last name | KAWANAKA |
Organization
Okayama University
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Okayama City, Okayama
TEL
086-235-7219
Homepage URL
m.kawanaka@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University
Address
2-5-1 Shikata-cho, Okayama City, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.ac.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
| 2026 | Year | 03 | Month | 05 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 03 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069302
