UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058898 |
|---|---|
| Receipt number | R000067358 |
| Scientific Title | Effects of fermented milk intake in the morning on body composition and intestinal bacteria |
| Date of disclosure of the study information | 2025/08/28 |
| Last modified on | 2025/08/26 11:34:56 |
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Basic information
Public title
Effects of fermented milk intake in the morning on body composition and intestinal bacteria
Acronym
Effects of fermented milk intake in the morning on body composition and intestinal bacteria
Scientific Title
Effects of fermented milk intake in the morning on body composition and intestinal bacteria
Scientific Title:Acronym
Effects of fermented milk intake in the morning on body composition and intestinal bacteria
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate effects of fermented milk intake in the morning on body composition and intestinal bacteria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass, intestinal bacteria
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake placebo in the morning for 12 weeks.
Interventions/Control_2
Intake milk protein in the morning for 12 weeks.
Interventions/Control_3
Intake fermented milk in the morning for 12 weeks.
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
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who aged 18-45.
Obtained written informed consent from the participant before participation.
Key exclusion criteria
Individuals who have high protein intake in the morning
Individuals who have milk allergies.
Individuals with diabetes, and dyslipidemia.
Individuals taking any antioxidant, anti-obesity, or antidiabetes medication and supplements
Individuals who suffered from sleep apnea
Individuals who have a habit of smoking
Individuals who are set pacemaker and metal in body (excluding dental filling).
Individuals who are engaged shift work and travel with jetlag within 2 weeks.
Individuals who have a habit of strength training
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takahashi |
Organization
Institute of Science Tokyo
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama Meguro-ku, Tokyo
TEL
03-5734-2904
takahashi.m.1483@m.isct.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Takahashi |
Organization
Institute of Science Tokyo
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama Meguro-ku, Tokyo
TEL
03-5734-2904
Homepage URL
takahashi.m.1483@m.isct.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
2-12-1, Ookayama Meguro-ku, Tokyo
Tel
03-5734-3808
hitorinri@jim.titech.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
| 2025 | Year | 08 | Month | 28 | 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
| 2025 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067358
