UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042747 |
|---|---|
| Receipt number | R000048764 |
| Scientific Title | The effect of milk protein intake and exercise practice on lower limb functions, autonomic nervous system and hemoglobin in older adults with a lower limb functions |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2022/06/17 09:03:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of milk protein intake and exercise practice on lower limb functions, autonomic nervous system and hemoglobin in older adults with a lower limb functions
Acronym
The effect of milk protein intake and exercise practice on lower limb functions, autonomic nervous system and hemoglobin
Scientific Title
The effect of milk protein intake and exercise practice on lower limb functions, autonomic nervous system and hemoglobin in older adults with a lower limb functions
Scientific Title:Acronym
The effect of milk protein intake and exercise practice on lower limb functions, autonomic nervous system and hemoglobin
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of milk protein intake and exercise practice on lower limb functions, autonomic nervous system and hemoglobin in older adults with lower limb functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
12 weeks after the start of food intake and exercise practice intervention
Strength of lower limbs during sit-to-stand
Key secondary outcomes
1) One-leg standing with eyes open
2) Sit and reach
3) Timed up and go
4) 5-m habitual walk
5) Autonomic nervous
6) Hemoglobin
7) Body compositions (height, weight, muscle mass, fat mass, bone mass)
8) Visual Analogue Scale (VAS) of bodily sensation
9) Cognitive functions: Trail Making Peg Test (TMP: executive functions), Five cognitive function test(attention, verbal memory, visuospatial cognition, word fluency, associate learning)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12 weeks of milk protein intake (5g/twice daily (breakfast/dinner)
Interventions/Control_2
12 weeks of milk protein intake (5g/twice daily (breakfast/dinner) and exercise practice (3 times/week at home (walking: 30 minutes + weight-bearing exercises: 20 minutes + stretching: 10 minutes))
Interventions/Control_3
Control(No treatment)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects without prohibition on exercise from a doctor
2) Subjects with the capacity to participate the study-related briefing sessions, examinations and measurements in University of Tsukuba by themselves
Key exclusion criteria
1) Subjects with paralysis
2) Subjects with allergies to supplements, milk components and soybean
3) Subjects who are involving in other clinical experiments currently or having participated in any other clinical experiments in the past 3 months
4) Subjects excluded as inappropriate participants by the lead principal investigator
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Okura |
Organization
University of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba
TEL
029-859-2733
okura.tomohiro.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Mijin |
| Middle name | |
| Last name | Kim |
Organization
University of Tsukuba
Division name
Industry-University Collaboration R&D Center for Tailor-Made QOL
Zip code
305-8550
Address
Innovation Medical Research Institute, Laboratory No. 407 1-2 Kasuga, Tsukuba, Ibaraki
TEL
029-859-1834
Homepage URL
mjmj0816@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Company Limited
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
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba
Tel
029-853-2571
tg-kenkyu@un.tsukuba.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
筑波大学（茨城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 31 | 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
| 2020 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | 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
| 2020 | Year | 12 | Month | 14 | Day |
Last modified on
| 2022 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048764
