UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050921 |
|---|---|
| Receipt number | R000058039 |
| Scientific Title | The effect of milk fat globule membrane ingestion combined with exercise on physical function |
| Date of disclosure of the study information | 2023/05/26 |
| Last modified on | 2024/08/09 11:26:42 |
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Basic information
Public title
The effect of milk-derived components ingestion combined with exercise on physical function
Acronym
The effect of milk-derived components ingestion combined with exercise on physical function
Scientific Title
The effect of milk fat globule membrane ingestion combined with exercise on physical function
Scientific Title:Acronym
The effect of milk fat globule membrane ingestion combined with exercise on physical function
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of milk fat globule membrane ingestion combined with exercise on physical function for 4 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle strength
Key secondary outcomes
Physical functions (muscle strength, agility, muscle power)
Electromyography
Body composition
Safety assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Light exercise (3 times per week)
Powder containing milk fat globule membrane, one pouch per day
4 weeks
Interventions/Control_2
Light exercise (3 times per week)
Placebo, one pouch per day
4 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males or females aged 20 to 49 years old
2) Give a written informed consent
Key exclusion criteria
1) Have motor dysfunction
2) Have previous/current history of diabetes, serious disorders of liver, kidney, cardiovascular, respiratory, cranial nerve, mental, and/or other serious and/or progressive diseases
3) Use implantable electronic medical devices
4) Restricted exercise, intense movement, or bathing by the doctor
5) Have milk or soy allergies
6) Pregnant, breastfeeding or may become pregnant
7) Use drugs that may affect the results of the study
8) Intake a lot of milk or daily products
9) Intake at least 5 g of whey protein per week
10) Smoker
11) Heavy drinker
12) BMI>=30
13) Involved in regular vigorous exercise
14) Have participated in other clinical trials in the last month, or plan to participate during this study period
15) Member of antisocial forces
16) Have received a notice of expulsion from employer or fitness club
17) Judged as unsuitable for the study by the principal investigator for other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Sanbongi |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919, Japan
TEL
+81-42-632-5846
chiaki.sanbongi@meiji.com
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Ito |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919, Japan
TEL
+81-42-632-5846
Homepage URL
kyouko.itou@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kao Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F,Daiwa Bldg.3-3-10 Nihonbashi Hongokucho,Chuo-ku,Tokyo 103-0021 Japan
Tel
+81-3-6225-9005
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
MIJ23C2
Org. issuing International ID_1
CPCC Company Limited
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 26 | 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
102
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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 02 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 14 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 25 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058039
