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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028560
Receipt No. R000032688
Scientific Title Effects of strength exercise and beta-hydroxy-beta-methylbutyrate (HMB) on muscle mass and function
Date of disclosure of the study information 2017/08/07
Last modified on 2019/08/09

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Basic information
Public title Effects of strength exercise and beta-hydroxy-beta-methylbutyrate (HMB) on muscle mass and function
Acronym Effects of strength exercise and beta-hydroxy-beta-methylbutyrate (HMB) on muscle mass and function
Scientific Title Effects of strength exercise and beta-hydroxy-beta-methylbutyrate (HMB) on muscle mass and function
Scientific Title:Acronym Effects of strength exercise and beta-hydroxy-beta-methylbutyrate (HMB) on muscle mass and function
Region
Japan

Condition
Condition Healthy older adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the combined effects of strength exercise and HMB supplement on skeletal muscle-related outcomes among older women with reduced muscle mass.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Muscle mass
Key secondary outcomes Muscle strength, muscle quality, skin quality, sarcopenia scale, blood samples, performance test, habitual physical activity, dietary intake, diary, and health-related questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 Phase 1 (12 weeks): Strength exercise (2 days/week) and HMB (1200 mg/day).
Washout (12 weeks).
Phase 2 (12 weeks): Health education (1 day/2 week) and placebo (every day)
Interventions/Control_2 Phase 1 (12 weeks): Strength exercise (2 days/week) and placebo (every day)
Washout (12 weeks)
Phase 2 (12 weeks): Health education (1 day/2 weeks) and HMB (1200 mg/day)
Interventions/Control_3 Phase 1 (12 weeks): Health education (1 day/2 weeks) and HMB (1200 mg/day)
Washout (12 weeks)
Phase 2 (12 weeks): Strength exercise (2 days/week) and placebo (every day)
Interventions/Control_4 Phase 1 (12 weeks): Health education(1 day/2 weeks) and placebo (every day)
Washout (12 weeks)
Phase 2 (12 weeks): Strength exercise (2 days/week) and HMB (1200 mg/day)
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

Not applicable
Gender Female
Key inclusion criteria Participants who
1) were older women aged 65 years and more.
2) had reduced muscle mass (SMI<5.7).
3) provided informed consent for screening.
Key exclusion criteria Participants who
1) were restricted from exercising by a medical doctor.
2) were taking other supplements for muscle mass gain.
3) had impaired cardiac (e.g., with cardiac pacemaker implants), kidney, and liver functions.
4) were judged ineligible by a medical doctor.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Hunkyung
Middle name
Last name Kim
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Promoting Independence of the Elderly
Zip code 173-0015
Address 35-2, Sakae-cho, Itabshi-ku, Tokyo
TEL 03-3964-3241
Email kimhk@tmig.or.jp

Public contact
Name of contact person
1st name Yosuke
Middle name
Last name Osuka
Organization Tokyo Metropolitan Institute of Gerontology
Division name Research Team for Promoting Independence of the Elderly
Zip code 173-0015
Address 35-2, Sakae-cho, Itabshi-ku, Tokyo
TEL 03-3964-3241
Homepage URL
Email osuka@tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization KYOWA Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor University of Tsukuba
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Metropolitan Institute of Gerontology Institutional Review Board
Address 35-2, Sakae-cho, Itabashi-ku, Tokyo
Tel 03-3964-3241
Email rinsyoushiken@tmghig.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 東京都健康長寿医療センター研究所(東京都)/Tokyo Metropolitan Institute of Gerontology (Tokyo)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 07 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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 14 Day
Date of IRB
2017 Year 09 Month 15 Day
Anticipated trial start date
2017 Year 10 Month 09 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 04 Month 15 Day
Date analysis concluded
2019 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 07 Day
Last modified on
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032688

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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