UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063346 |
|---|---|
| Receipt number | R000072506 |
| Scientific Title | A study on the effects of test food intake on bone-related markers in adult men and women |
| Date of disclosure of the study information | 2026/11/03 |
| Last modified on | 2026/10/19 18:56:35 |
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Basic information
Public title
A study on the effects of test food intake on bone-related markers in adult men and women
Acronym
A study on the effects of test food intake on bone-related markers in adult men and women
Scientific Title
A study on the effects of test food intake on bone-related markers in adult men and women
Scientific Title:Acronym
A study on the effects of test food intake on bone-related markers in adult men and women
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 96 weeks of continuous test food intake on bone-related markers in adult men and women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c (whole blood)
Key secondary outcomes
HbA1c (serum), blood and urinary pentosidine, blood creatinine, urinary albumin, blood and urinary bone metabolism markers, blood metabolomic profiling, and nutrient intake questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One bottle of the test food will be consumed daily for 96 weeks.
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Subjects who are men or women aged 40 years or older and younger than 65 years at the time of informed consent.
(2) Subjects who self-report having elevated blood glucose levels.
(3) Subjects with elevated HbA1c and urinary pentosidine levels at the screening examination.
(4) Subjects who have sufficiently understood the purpose and procedures of the study and have voluntarily provided written informed consent to participate in the study.
Key exclusion criteria
(1) Subjects with a BMI of 25.0 kg/m 2 or higher.
(2) Subjects who regularly consume health foods or dietary supplements that may affect bone-related markers (e.g., dairy products, calcium, vitamin D, vitamin K, or multi-ingredient supplements containing these ingredients).
(3) Subjects with a history of abnormal clinical laboratory values or cardiopulmonary function and who are judged to be unsuitable for participation in the study.
(4) Subjects who may develop allergic reactions related to the study.
(5) Subjects with diseases requiring continuous medication (including topical and oral medications), subjects currently receiving treatment for any disease (except dry eye and dental caries), subjects with a history of serious disease requiring pharmacological treatment, or subjects with a history of diseases that may affect bone-related markers.
(6) Subjects with markedly abnormal physical measurements, physical examination findings, or clinical laboratory values prior to the start of test food intake.
(7) Subjects with irregular lifestyles, such as those engaged in shift work or night work.
(8) Subjects who have participated in another clinical study, clinical trial, or human study within 1 month prior to the start of this study.
(9) Subjects who are pregnant, lactating, or planning to become pregnant during the study period.
(10) Subjects judged to be unsuitable for participation in the study based on the responses to the lifestyle questionnaire.
(11) Subjects who are otherwise judged by the principal investigator to be unsuitable for participation in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ueno |
Organization
MEGMILK SNOW BRAND Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2, Minamidai, Kawagoe-shi, Saitama
TEL
049-242-8060
hiroshi-ueno@meg-snow.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
Organization
EP-DataWeave Co., Ltd.
Division name
Food Development Business Department, Trial Planning Section
Zip code
162-0814
Address
Acropolis Tokyo, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo
TEL
090-4821-1099
Homepage URL
yamamichi.shingo578@eps.co.jp
Sponsor or person
Institute
EP-DataWeave Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.co.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
メディカルステーションクリニック (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 03 | 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 | 10 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 15 | 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 | 10 | Month | 19 | Day |
Last modified on
| 2026 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072506
