UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052127 |
|---|---|
| Receipt number | R000059497 |
| Scientific Title | Combined effects of morning milk ingestion and exercise on muscle mass, fitness, and biological clock function among community-dwelling older adults |
| Date of disclosure of the study information | 2023/09/08 |
| Last modified on | 2024/03/25 09:43:18 |
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Basic information
Public title
Combined effects of morning milk ingestion and exercise on muscle mass, fitness, and biological clock function among community-dwelling older adults
Acronym
Combined effects of morning milk ingestion and exercise on muscle mass, fitness, and biological clock function among community-dwelling older adults
Scientific Title
Combined effects of morning milk ingestion and exercise on muscle mass, fitness, and biological clock function among community-dwelling older adults
Scientific Title:Acronym
Combined effects of morning milk ingestion and exercise on muscle mass, fitness, and biological clock function among community-dwelling older adults
Region
| Japan |
Condition
Condition
Long-term care
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether morning milk consumption combined with exercise improves skeletal muscle mass, physical fitness, and biological clock function in community-dwelling older adults, when compared to exercise alone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
muscle mass
Key secondary outcomes
muscle strength, cardiorespiratory fitness, body fat, walking speed, mitochondrial function, frailty index, wake/sleep time, morningness/eveningness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Participants in the intervention group will be insturctred to consume dairy products (daily) and engage in exercise (at least twice a week) for 12 weeks.
Interventions/Control_2
Participants in the contorl group will be insturctred to engage in exercise (at least twice a week) for 12 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
| 65 | years-old | <= |
Age-upper limit
| 91 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Those who consume instructed dairy products every morning for a period of twelve weeks
2) Those who are able to exercise at least twice a week on a continuous basis
3) 65 years of age or older at the time of consenting to the study
4) Have obtained written consent to participate in the study
Key exclusion criteria
1) Those who consume large amounts of milk on a daily basis
2) Those who have allergic reactions to milk intake or lactose intolerance (abdominal pain or diarrhea)
3) Those who exercise is contraindicated by their family physician
4) Those whose systolic blood pressure at rest is 180 mHg or higher
5) Those who have difficulty in lower limb movement (knee extension and flexion)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Miyazaki |
Organization
Shimane University
Division name
Faculty of Human Sciences
Zip code
690-8504
Address
1060 Nishikawatsu, Matsue City, Shimane
TEL
0852-32-9059
miyazaki@hmn.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Miyazaki |
Organization
Shimane University
Division name
Faculty of Human Sciences
Zip code
690-8504
Address
1060 Nishikawatsu, Matsue City, Shimane
TEL
0852-32-9059
Homepage URL
miyazaki@hmn.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Ryo Miyazaki
Funding Source
Organization
J-MILK
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Shimane University School of Medicine
Address
89-1, Enyacho, Izumo-shi, Shimane
Tel
0853-20-2259
kenkyu@med.shimane-u.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
| 2023 | Year | 09 | Month | 08 | 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
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059497
