UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061518 |
|---|---|
| Receipt number | R000069633 |
| Scientific Title | Yamanashi Multi-omics Cohort (YMoC) Study for Simulation of Human Metabolic States |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/11 11:56:19 |
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Basic information
Public title
Yamanashi Multi-omics Cohort (YMoC) Study for Simulation of Human Metabolic States
Acronym
YMoC Study
Scientific Title
Yamanashi Multi-omics Cohort (YMoC) Study for Simulation of Human Metabolic States
Scientific Title:Acronym
YMoC
Region
| Japan |
Condition
Condition
Prediabetes, Healthy individuals
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In this study, we focus on insulin resistance, a key factor underlying metabolic deterioration. By longitudinally collecting omics data and lifestyle information from individuals with mild glucose intolerance, we aim to characterize the progression of metabolic adaptations that underlie the development of lifestyle-related diseases and to identify biological markers and lifestyle factors associated with their regulation.
In a preceding study entitled "A multi-omics cohort study to identify metabolic transitions underlying the development of lifestyle-related diseases," integrated analyses of longitudinal proteomics and lifestyle data suggested associations between changes in insulin resistance and several candidate plasma proteins as well as lifestyle-related factors. In addition, the use of wearable devices and smartphone applications enabled the collection of behavioral data and demonstrated the feasibility of analyzing relationships between daily behaviors, such as physical activity and sleep, and metabolism-related proteins.
The primary objective of the present study is to validate these findings in an independent cohort population. Specifically, we will longitudinally collect omics data, including plasma proteomics, together with lifestyle data among individuals with mild glucose intolerance to examine the reproducibility of biomolecules and lifestyle behaviors associated with changes in insulin resistance and to analyze the progression of metabolic states.
In addition, this study includes an intervention component using the smartphone application Taohealth to support lifestyle improvement. The application provides AI-based health behavior advice based on questionnaire responses and wearable-derived data on physical activity and sleep. These data will be used to analyze relationships between lifestyle behavior changes and metabolic indicators and to exploratorily evaluate the effects of lifestyle interventions on metabolic states.
Basic objectives2
Others
Basic objectives -Others
To validate the progression of metabolic adaptation identified in the preceding study.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of proteome (protein) networks associated with changes in insulin resistance (HOMA-R).
Key secondary outcomes
Identification of activity monitor data and health behavior indicators associated with changes in the identified proteome networks.
Identification of SNPs, DNA methylation, RNA, metabolome, microbiome, miRNA, cfDNA, and exosomes associated with changes in insulin resistance (HOMA-R).
Identification of physical activity and behavioral change indicators associated with the identified SNPs, DNA methylation, RNA, metabolome, microbiome, miRNA, cfDNA, and exosomes.
Examination of correlations among each omics modality (SNPs, DNA methylation, RNA, proteome, metabolome, microbiome, miRNA, cfDNA, and exosomes).
Examination of the correlation between dietary records collected through the health record application (Taohealth) and the food frequency questionnaire (FFQ).
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
AI feedback from Taohealth App
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
| 25 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who underwent a comprehensive health check-up or periodic health examination between fiscal years 2024 and 2026 and meet the following criteria will be eligible for inclusion.
1. The age at the time of examination is between 25 and 70 years, inclusive.
2. The fasting plasma glucose level at the time of examination is 100 mg/dL or higher and 125 mg/dL or lower.
3. The HbA1c level at the time of examination is less than 6.5%.
4. Based on the questionnaire at the time of examination, the individual reports not taking any medication for type 2 diabetes.
5. Written informed consent for participation in this study has been obtained.
Key exclusion criteria
Individuals who meet any of the following criteria will be excluded from the study.
1. Individuals who are considered unable to adequately understand the study explanation due to cognitive impairment, severe psychiatric disorders, serious physical illness, or other similar conditions, or who are judged to have difficulty participating in the study or undergoing the required examinations.
2. Individuals who do not possess a smartphone.
3. Individuals who are unable to communicate smoothly in Japanese.
4. Individuals who are judged by the principal investigator to have other conditions that make them inappropriate for participation in this study.
Target sample size
1012
Research contact person
Name of lead principal investigator
| 1st name | Tadao |
| Middle name | |
| Last name | Ooka |
Organization
University of Yamanashi
Division name
Department of Health Sciences
Zip code
409-3898
Address
1110, Shimokato, Chuo, Yamanashi
TEL
0552739566
tohoka@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Ooka |
Organization
University of Yamanashi
Division name
Department of Health Sciences
Zip code
409-3898
Address
1110, Shimokato, Chuo, Yamanashi
TEL
0552739566
Homepage URL
tohoka@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Yamanashi
Address
1110, Shimokato, Chuo, Yamanashi
Tel
055-273-1111
rec-med@yamanashi.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 | 05 | Month | 11 | 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 | 31 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2031 | 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 | 05 | Month | 11 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069633
