UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061879 |
|---|---|
| Receipt number | R000070801 |
| Scientific Title | An Exploratory Study Evaluating the Effects of a Test Food on Aging-Related Indicators - Single-arm, open-label study - |
| Date of disclosure of the study information | 2026/06/11 |
| Last modified on | 2026/06/11 18:03:02 |
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Basic information
Public title
An Exploratory Study Evaluating the Effects of a Test Food on Aging-Related Indicators - Single-arm, open-label study -
Acronym
An Exploratory Study Evaluating the Effects of a Test Food on Aging-Related Indicators - Single-arm, open-label study -
Scientific Title
An Exploratory Study Evaluating the Effects of a Test Food on Aging-Related Indicators - Single-arm, open-label study -
Scientific Title:Acronym
An Exploratory Study Evaluating the Effects of a Test Food on Aging-Related Indicators - Single-arm, open-label study -
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effects of continuous intake of the test food on Aging-Related Indicator in adult men and women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of Aging-Related Indicators after continuous consumption of research food for 24 weeks.
Key secondary outcomes
BMI,questionnaire, hematologic test, blood biochemistry test
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
Intake of test food for 24 weeks (once a day, 3 capsules)
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 40-55 years
2) BMI >=25.0 and <30.0 kg/m2
3) Subjects who received a full explanation of the study objectives and procedures, understood the information, voluntarily agreed to participate, and provided written informed consent
Key exclusion criteria
1) Subjects with diabetes mellitus; receiving pharmacological treatment within the past 6 months; or with a history of renal, hepatic, cardiac, or other diseases considered unsuitable for participation.
2) Subjects regularly consuming foods, supplements, or medications that may affect the intestinal environment (e.g., probiotics, prebiotics, dietary fiber supplements, intestinal regulators, laxatives, or antibiotics).
3) Subjects with lactose intolerance or diarrhea following dairy consumption.
4) Subjects with diarrhea after alcohol consumption, except those who do not habitually consume alcohol and agree to abstain throughout the study.
5) Subjects engaged in shift work, irregular work schedules, physically demanding labor, irregular holidays, or frequent night shifts during the study period.
6) Subjects planning significant lifestyle changes during the study period.
7) Subjects smoking >=21 cigarettes/day.
8) Subjects consuming excessive alcohol (>=21 g alcohol/day).
9) Subjects consuming excessive caffeinated beverages (>=7 cups of coffee/day).
10) Subjects with self-reported food allergies.
11) Subjects who are pregnant, breastfeeding, or planning pregnancy during the study period.
12) Subjects who participated in another clinical study within 1 month before informed consent or plan to participate in another study during the study period.
13) Subjects who donated 200 mL or 400 mL whole blood, received a blood transfusion within 3 months before testing, or donated blood components within 2 weeks before testing.
14) Subjects deemed unsuitable based on screening assessments.
15) Subjects currently participating in, or intending to participate in, another study involving foods, medications, cosmetics, quasi-drugs, or pharmaceuticals.
16) Subjects otherwise judged unsuitable by the principal investigator or sub-investigators.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Nakagawa |
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
049-242-8165
hisako-nakagawa@meg-snow.com
Public contact
Name of contact person
| 1st name | Hisako |
| Middle name | |
| Last name | Nakagawa |
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
049-242-8165
Homepage URL
hisako-nakagawa@meg-snow.com
Sponsor or person
Institute
Medical Corporation Heishinkai ToCROM Clinic
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 Corporation Heishinkai OPHAC Hospital
Address
4-1-29 Miyahara, Yodogawa-ku, Osaka, 532-0003, Japan
Tel
06-6394-9900
sumiko.kawamoto@incrom.com
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
医療法人平心会 ToCROMクリニック
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | 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 | 04 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 12 | 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 | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070801
