UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062462 |
|---|---|
| Receipt number | R000071465 |
| Scientific Title | An Exploratory Study on Blood microRNAs Following Chocolate Ingestion |
| Date of disclosure of the study information | 2026/08/04 |
| Last modified on | 2026/08/03 17:26:05 |
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Basic information
Public title
An Exploratory Study on Blood microRNAs Following Chocolate Ingestion
Acronym
An Exploratory Study on Blood microRNAs Following Chocolate Ingestion
Scientific Title
An Exploratory Study on Blood microRNAs Following Chocolate Ingestion
Scientific Title:Acronym
An Exploratory Study on Blood microRNAs Following Chocolate Ingestion
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to evaluate the relationship between serum microRNAs, body composition, and blood biomarkers in men and women aged 60 to 79 years following 16 weeks of continuous chocolate ingestion.
No new interventions will be conducted in this study; stored serum samples and clinical data previously collected in the UMIN000054576 study will be utilized.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes over time in normalized delta Ct values of serum microRNAs (up to approximately 10 types) before ingestion, and at 8 and 16 weeks after ingestion in the non-ingestion group and the chocolate ingestion group.
The primary analysis will evaluate the group-by-time interaction.
Key secondary outcomes
Association between changes in normalized delta Ct values of serum microRNAs and changes in body composition parameters, blood markers, etc.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects randomized to the non-ingestion group or the chocolate intervention group within the efficacy analysis population of UMIN000054576.
2. Subjects who agree to the secondary use of samples and data collected in UMIN000054576.
Key exclusion criteria
Subjects who decline the use of their samples or data for this study.
Target sample size
148
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
069-8585
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL
011-385-4430
hisc-acad.res@s.do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | HONMA |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
069-0832
Address
45-7, Nishi-nopporo, Ebetsu, Hokkaido, 069-0832, Japan
TEL
011-385-4430
Homepage URL
hisc-acad.res@s.do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings Co., Ltd.
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Hokkaido Information University
Address
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
Tel
011-385-4411
soumu@do-johodai.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
北海道情報大学 健康情報科学研究センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 04 | 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
| 2026 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 07 | 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
No new interventions will be conducted in this study; stored serum samples and clinical data previously collected in the UMIN000054576 study will be utilized.
Management information
Registered date
| 2026 | Year | 08 | Month | 04 | Day |
Last modified on
| 2026 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071465
