UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028142 |
|---|---|
| Receipt number | R000031939 |
| Scientific Title | The effect of beta-hydroxy-beta-methylbutyrate with resistance training on the skeletal muscle and the skin in postmenopausal women: A preliminary trial |
| Date of disclosure of the study information | 2017/07/08 |
| Last modified on | 2019/01/08 12:12:15 |
* 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 beta-hydroxy-beta-methylbutyrate with resistance training on the skeletal muscle and the skin in postmenopausal women: A preliminary trial
Acronym
The effect of beta-hydroxy-beta-methylbutyrate
with resistance training on the skeletal muscle and the skin
Scientific Title
The effect of beta-hydroxy-beta-methylbutyrate with resistance training on the skeletal muscle and the skin in postmenopausal women: A preliminary trial
Scientific Title:Acronym
The effect of beta-hydroxy-beta-methylbutyrate
with resistance training on the skeletal muscle and the skin
Region
| Japan |
Condition
Condition
postmenopausal
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Obstetrics and Gynecology | Dermatology | Orthopedics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of beta-hydroxy-beta-methylbutyrate with resistance training on the skeletal muscle and the skin on postmenopausal women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Skeletal muscle mass,
Key secondary outcomes
transepidermal water transpiration amount
Maximum muscular strength
performance test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom | Other |
Interventions/Control_1
A 12 weeks HMB and resistance training.
Interventions/Control_2
No treatment.
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
Postmenopausal women.
Non smoker.
Non exercise habit.
Key exclusion criteria
Participation in other intervention.
Coronary or kidney, or liver disease.
Skin disorder.
Contraindication of exercise at a physician's direction.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoji Tanaka |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-2655
tanaka.kiyoji.ft@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoji Tanaka |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-2655
Homepage URL
tanaka.kiyoji.ft@u.tsukuba.ac.jp
Sponsor or person
Institute
Faculty of Health and Sport Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
KYOWA Co, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 07 | 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
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 08 | Day |
Last modified on
| 2019 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031939
