UMIN-CTR Clinical Trial

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
Email	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
Email	mjmj0816@gmail.com

Sponsor
Institute	University of Tsukuba
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048764