UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061121 |
|---|---|
| Receipt number | R000069936 |
| Scientific Title | Nutritional Approaches to Improving Liver Function Biomarkers in Heavyweight Athletes |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/31 21:31:52 |
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Basic information
Public title
Nutritional Intervention Trial to Improve Liver Function Related Blood Biomarkers in Heavyweight Athletes
Acronym
Nutritional Intervention Trial in Heavyweight Athletes
Scientific Title
Nutritional Approaches to Improving Liver Function Biomarkers in Heavyweight Athletes
Scientific Title:Acronym
Nutritional Intervention Trial in Heavyweight Athletes
Region
| Japan |
Condition
Condition
obesity Liver dysfunction
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify factors that influence blood biomarkers related to liver function in athletes and to examine nutritional strategies aimed at improving these biomarkers. To achieve this, a three-month nutrition counseling program conducted by a registered dietitian will be implemented. By targeting athletes with impaired liver function, this study aims to clarify dietary approaches that may improve liver dysfunction that is non-alcoholic in origin and not attributable to physical inactivity or overeating.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of improvement in serum ALT levels after the 3-month nutritional intervention
Key secondary outcomes
This study will collect body composition data, energy and nutrient intake, and a comprehensive panel of blood biomarkers, including hemoglobin, hematocrit, MCV, MCH, MCHC, white blood cell count, platelet count, AST, ALT, GTP, total protein, albumin, aldolase, total bilirubin, uric acid, creatinine, LDH, ALP, CK, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, total bile acids, blood glucose, HbA1c, and the FIB-4 index. Salivary biomarkers such as cortisol, secretory IgA, and IL-6 will also be assessed. In addition, abdominal ultrasound parameters (liver stiffness, attenuation imaging value, and attenuation coefficient) and abdominal MRI parameters (proton density fat fraction, visceral fat area, and subcutaneous fat area) will be evaluated. Training status, psychological status, and sleep status will likewise be recorded.
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
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom | Other |
Interventions/Control_1
Participants will be selected based on screening blood tests, specifically those with AST and ALT levels of >30 mg/dL and not markedly exceeding 40 mg/dL. Individuals who are found to have fatty liver on MRI and are deemed to require medical treatment will be excluded. The athletes who meet the criteria will undergo approximately three months of nutrition management provided by a registered dietitian, with the aim of improving liver function. Body composition, blood, salivary, ultrasound, and MRI biomarkers, as well as nutrient intake, will be assessed before and after the intervention to evaluate the effects of the nutritional program.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Individuals will be selected based on screening blood tests conducted in heavyweight athletes, specifically those with AST and ALT levels of >30 mg/dL and not markedly exceeding 40 mg/dL.
Key exclusion criteria
Participants who are found to have fatty liver on MRI and are judged by a physician to require medical treatment will be excluded from the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | MEGUMI |
| Middle name | |
| Last name | MATSUMOTO |
Organization
College of Humanities and Sciences,Nihon University
Division name
Department of Physical Education
Zip code
156-8550
Address
3-25-40, Sakurajosui, Setagaya-ku, Tokyo
TEL
0353179717
matsumoto.megumi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | MEGUMI |
| Middle name | |
| Last name | MATSUMOTO |
Organization
College of Humanities and Sciences,Nihon University
Division name
Department of Physical Education
Zip code
156-8550
Address
3-25-40, Sakurajosui, Setagaya-ku, Tokyo
TEL
0353179717
Homepage URL
matsumoto.megumi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Megumi MATSUMOTO
Funding Source
Organization
Nihon University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University
Address
3-25-40, Sakurajosui, Setagaya-ku, Tokyo, 156-8550, JAPAN
Tel
0353179717
matsumoto.megumi@nihon-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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069936
